Nexium (esomeprazole) in Symptom adapted therapy in GERD Patients - MAESTRO

Study identifier:D9612L00111

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, open, parallel-group study to evaluate the efficacy of three different patient management strategies during a 12 weeks maintenance phase following an initial 4-weeks acute treatment phase in subjects with symptoms thought to be GERD related

Medical condition

GERD

Phase

Phase 4

Healthy volunteers

Study drug

esomeprazole (Nexium®), Xolaam®

Sex

All

Actual Enrollment

3029

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Mar 2007

Primary Completion Date: 01 Oct 2008

Study Completion Date: 01 Oct 2008

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Rouen, France

Arms	Assigned Interventions
Experimental: Esomeprazole 20 mg Once Daily (initial phase)	Drug: esomeprazole (Nexium®) This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
Experimental: Esomeprazole 40 mg Once Daily (initial phase)	Drug: esomeprazole (Nexium®) This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
Experimental: Esomeprazole 20 mg Once Daily (Maintenance Phase)	Drug: esomeprazole (Nexium®) This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
Experimental: Esomeprazole 20 mg on Demand (Maintenance Phase)	Drug: esomeprazole (Nexium®) This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed
Experimental: Antacid Treatment (Maintenance Phase)	Drug: Xolaam® This randomized study was conducted on parallel groups and included two phases: - One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator’s decision - One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited by general practitioner between March 1, 2007 and July 21, 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study included 2 phases (maximum treatment duration = 16 weeks): -one initial treatment phase of 4 weeks -one randomized maintenance treatment phase of 12 weeks only for patients whose initial treatment is considered to be successful at the end of the initial phase. Only maintenance phase data were reported in the Baseline module measures.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Participant Flow for 2 periods

Period 1: initial treatment phase

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)
STARTED	2156	873
COMPLETED	1908	777
NOT COMPLETED	248	96

Period 2: maintenance treatment phase

	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
STARTED	908	897	880
COMPLETED	747	764	701
NOT COMPLETED	161	133	179
Didn'r receive the treatment	22	17	29
Lost to Follow-up	8	14	10
Adverse Event	3	2	13
Protocol specific criteria's development	1	0	6
Patient's wish	19	9	20
Protocol Violation	103	88	87
Ineffectiveness	5	3	14

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Baseline Measures

	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)	Total
Number of Participants [units: Participants]	871	857	830	2558
Age Continuous [units: years] Mean ± Standard Deviation	41.5 ± 9.83	41.79 ± 9.97	41.6 ± 10	41.64 ± 9.91
Gender, Male/Female [units: Participants]
Female	449	415	411	1275
Male	422	442	419	1283

Outcome Measures

1. Primary Outcome Measure: Efficacy of three strategies of long-term treatment [ Time Frame: 16 weeks ]

Measure Type	Primary
Measure Name	Efficacy of three strategies of long-term treatment
Measure Description	Percentage of failure of maintenance treatment between V2 (4 weeks) and V3 (16 weeks) evaluated by the patient, defined based on responses to 2 questions (if at least 1 negative response was given, the patient was considered to be in failure) : Did the treatment produce sufficient control of reflux symptoms? Do you wish to continue the treatment?
Time Frame	16 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	871	857	830
Efficacy of three strategies of long-term treatment [units: Percentage of participants with failure]	10.6	7.8	43

No statistical analysis provided for Efficacy of three strategies of long-term treatment

2. Secondary Outcome Measure: Difference in symptom severity evaluation performed by the investigators, when symptom severity is assessed with and without Reflux Disease Questionnaire (RDQ). [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Difference in symptom severity evaluation performed by the investigators, when symptom severity is assessed with and without Reflux Disease Questionnaire (RDQ).
Measure Description	Total percentage of subjects for whom evaluation of symptom severity using the Reflux Disease Questionnaire (RDQ) is different, either positively or negatively, as compared to clinical judgment made by Investigator. The RDQ Includes 12 Items: 6 Concern the Frequency of Symptoms Ranging From "Never" for the Lowest Frequency to "Every Day" for the Highest, 6 Others Assess the Severity of Symptoms From "Not at All" to "Strong". The Total Score of the RDQ, Ranging From 0 to 40, is Obtained by Adding the Scores of Each Item.
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	1909	778	0	0	0
Difference in symptom severity evaluation performed by the investigators, when symptom severity is assessed with and without Reflux Disease Questionnaire (RDQ). [units: Percentage of participants]	3.7	2.3

No statistical analysis provided for Difference in symptom severity evaluation performed by the investigators, when symptom severity is assessed with and without Reflux Disease Questionnaire (RDQ).

3. Secondary Outcome Measure: Impact of treatment with low dose aspirin (Acetyl Salicylic Acid) used concomitantly during the initial phase and the maintenance phase [ Time Frame: 4 weeks ]

Measure Type	Secondary
Measure Name	Impact of treatment with low dose aspirin (Acetyl Salicylic Acid) used concomitantly during the initial phase and the maintenance phase
Measure Description	No possibility to describe as only 2 patients took ASA
Time Frame	4 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Outcome measure not possible to describe as only 2 patients took Aspirin.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	0	0	0	0	0
Impact of treatment with low dose aspirin (Acetyl Salicylic Acid) used concomitantly during the initial phase and the maintenance phase [units: ] ()

No statistical analysis provided for Impact of treatment with low dose aspirin (Acetyl Salicylic Acid) used concomitantly during the initial phase and the maintenance phase

4. Secondary Outcome Measure: Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) [ Time Frame: 4 to 16 weeks ]

Measure Type	Secondary
Measure Name	Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)
Measure Description	Change in values of upper digestive symptoms (GORD Impact Scale) from week 4 to week 16. Scale of 1 to 4 : 1 = every day, 2 = often, 3 = sometime, 4 = never)
Time Frame	4 to 16 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
871 (-66 missing data, 801 (-56 missing data), 833 (-75 missing data)

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	0	0	871	801	833
Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase) [units: Scores on scale] Mean (Standard Deviation)			0.12 (0.79)	0.04 (0.73)	-0.22 (0.8)

No statistical analysis provided for Differences Among Strategies of Maintenance Treatment for Satisfaction of the Patient, Using the GIS (Gord Impact Scale) Scale.(Change in values of Score Derived From the GIS Questionnaire From V2 to V3 = Start to End of the Maintenance Phase)

5. Secondary Outcome Measure: Impact of anxiety and depression during the initial visit measured by the HADS ( Hospital anxiety and Depression scale) questionnaire on response to initial treatment and to maintenance treatment [ Time Frame: 16 weeks ]

Measure Type	Secondary
Measure Name	Impact of anxiety and depression during the initial visit measured by the HADS ( Hospital anxiety and Depression scale) questionnaire on response to initial treatment and to maintenance treatment
Measure Description	Failure of treatment (as defined as in primary outcome measure) according to confirmed anxiety and depression during maintenance treatment evaluated by the patient via the score of HADS questionnaire. HADS scale ranges= 0 to 21 (the higher score, the worse : ≤7 : no anxiety-depression/ [8-10] : possible anxiety-depression/ >10 : anxiety-depression)
Time Frame	16 weeks
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	0	0	871	857	830
Impact of anxiety and depression during the initial visit measured by the HADS ( Hospital anxiety and Depression scale) questionnaire on response to initial treatment and to maintenance treatment [units: Percent of participants with failure]			9.8	9.3	43.7

No statistical analysis provided for Impact of anxiety and depression during the initial visit measured by the HADS ( Hospital anxiety and Depression scale) questionnaire on response to initial treatment and to maintenance treatment

6. Secondary Outcome Measure: Number of participants and type of serious adverse events and adverse events leading to a premature discontinuation of the study [ Time Frame: 12 weeks - maintenance treatment phase ]

Measure Type	Secondary
Measure Name	Number of participants and type of serious adverse events and adverse events leading to a premature discontinuation of the study
Measure Description	Number of participants with serious adverse events and adverse events leading to study treatment discontinuation. AE and SAE as defined in ICH-GCP.
Time Frame	12 weeks - maintenance treatment phase
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	0	0	886	880	851
Number of participants and type of serious adverse events and adverse events leading to a premature discontinuation of the study [units: Participants]			5	4	15

No statistical analysis provided for Number of participants and type of serious adverse events and adverse events leading to a premature discontinuation of the study

7. Secondary Outcome Measure: Score abacuses based on the Reflux Disease Questionnaire (RDQ) questionnaire [ Time Frame: Day 0 ]

Measure Type	Secondary
Measure Name	Score abacuses based on the Reflux Disease Questionnaire (RDQ) questionnaire
Measure Description	May be used to evaluate the severity of symptoms during the initial visit. Not done
Time Frame	Day 0
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The results of exploratory analyses are not available.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	0	0	0	0	0
Score abacuses based on the Reflux Disease Questionnaire (RDQ) questionnaire [units: ] ()

No statistical analysis provided for Score abacuses based on the Reflux Disease Questionnaire (RDQ) questionnaire

8. Secondary Outcome Measure: Score abacuses based on the Reflux Disease Questionnaire (RDQ) questionnaire [ Time Frame: Day 0 ]

Measure Type	Secondary
Measure Name	Score abacuses based on the Reflux Disease Questionnaire (RDQ) questionnaire
Measure Description	May be used to offer patients a strategy of treatment during the initial phase and in the long term. Not done
Time Frame	Day 0
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The results of exploratory analyses are not available.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	0	0	0	0	0
Score abacuses based on the Reflux Disease Questionnaire (RDQ) questionnaire [units: ] ()

No statistical analysis provided for Score abacuses based on the Reflux Disease Questionnaire (RDQ) questionnaire

9. Secondary Outcome Measure: Score abacuses based on the Reflux Disease Questionnaire (RDQ) [ Time Frame: Week 4 ]

Measure Type	Secondary
Measure Name	Score abacuses based on the Reflux Disease Questionnaire (RDQ)
Measure Description	May be used to define the success of treatment. Not done
Time Frame	Week 4
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The results of exploratory analyses are not available.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)
esomeprazole 40 mg once daily (initial phase)
esomeprazole 20 mg once daily (maintenance phase)
esomeprazole 20 mg on demand (maintenance phase)
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Measured Values

	esomeprazole 20 mg once daily (initial phase)	esomeprazole 40 mg once daily (initial phase)	esomeprazole 20 mg once daily (maintenance phase)	esomeprazole 20 mg on demand (maintenance phase)	antacid treatment (maintenance phase)
Number of Participants Analyzed [units:participants]	0	0	0	0	0
Score abacuses based on the Reflux Disease Questionnaire (RDQ) [units: ] ()

No statistical analysis provided for Score abacuses based on the Reflux Disease Questionnaire (RDQ)

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)	No text entered.
esomeprazole 40 mg once daily (initial phase)	No text entered.
esomeprazole 20 mg once daily (maintenance phase)	No text entered.
esomeprazole 20 mg on demand (maintenance phase)	No text entered.
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Serious Adverse Events

esomeprazole 20 mg once daily (initial phase)

esomeprazole 40 mg once daily (initial phase)

esomeprazole 20 mg once daily (maintenance phase)

esomeprazole 20 mg on demand (maintenance phase)

antacid treatment (maintenance phase)

Total, serious adverse events

# participants affected / at risk

8/2156 (0.37%)

2/873 (0.23%)

2/886 (0.23%)

3/880 (0.34%)

4/851 (0.47%)

Gastrointestinal disorders

ACUTE BALTHAZAR E PANCREATITIS¹

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

GASTRIC ULCER¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

1/880 (0.11%)

0/851 (0.00%)

Psychiatric disorders

ANXIO-DEPRESSI VE STATE¹

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Musculoskeletal and connective tissue disorders

AGGRAVATION OF INTERVERTEBRAL DISC HERNIATION¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

Pregnancy, puerperium and perinatal conditions

Abortion spontaneous¹

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Renal and urinary disorders

RENAL COLIC¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

Gastrointestinal disorders

EROSIVE ANTRITIS¹

# participants affected / at risk

0/2156 (0.00%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

BRONCHIAL CANCER¹

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Musculoskeletal and connective tissue disorders

SPONDYLOLISTHE SIS AGGRAVATION BY L5 SPONDYLOLYSIS¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

1/886 (0.11%)

0/880 (0.00%)

0/851 (0.00%)

Psychiatric disorders

DEPRESSION¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

1/880 (0.11%)

0/851 (0.00%)

Respiratory, thoracic and mediastinal disorders

PNEUMOPATHY¹

# participants affected / at risk

0/2156 (0.00%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Cardiac disorders

MYOCARDIAL INFARCTION¹

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

ADENOCARCINOM A OF GASTRIC ANTRUM¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

Infections and infestations

DIGESTIVE VIROSIS¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

1/880 (0.11%)

0/851 (0.00%)

Psychiatric disorders

DEPRESSIVE DISEASE¹

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

CARCINOMA OF OESOPHAGUS¹

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

General disorders

PREEXISTING LUNG CARCINOMA AGGRAVATION¹

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

ADENOMATOUS POLYP¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

1/886 (0.11%)

0/880 (0.00%)

0/851 (0.00%)

Reproductive system and breast disorders

METRORRHAGIA¹

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
esomeprazole 20 mg once daily (initial phase)	No text entered.
esomeprazole 40 mg once daily (initial phase)	No text entered.
esomeprazole 20 mg once daily (maintenance phase)	No text entered.
esomeprazole 20 mg on demand (maintenance phase)	No text entered.
antacid treatment (maintenance phase)	antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)

Other Adverse Events

esomeprazole 20 mg once daily (initial phase)

esomeprazole 40 mg once daily (initial phase)

esomeprazole 20 mg once daily (maintenance phase)

esomeprazole 20 mg on demand (maintenance phase)

antacid treatment (maintenance phase)

Total, other (not including serious) adverse events

# participants affected / at risk

32/2156 (1.48%)

16/873 (1.83%)

5/886 (0.56%)

2/880 (0.23%)

13/851 (1.53%)

Vascular disorders

Dyspepsia¹

# participants affected / at risk

2/2156 (0.09%)

2/873 (0.23%)

1/886 (0.11%)

1/880 (0.11%)

3/851 (0.35%)

Gastrointestinal disorders

Diarrhea²

# participants affected / at risk

3/2156 (0.14%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

Nervous system disorders

Headache²

# participants affected / at risk

5/2156 (0.23%)

2/873 (0.23%)

1/886 (0.11%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Epigastric discomfort²

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Constipation²

# participants affected / at risk

2/2156 (0.09%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

General disorders and administration site conditions

Chest pain²

# participants affected / at risk

0/2156 (0.00%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Gastritis²

# participants affected / at risk

1/2156 (0.05%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Abdominal pain²

# participants affected / at risk

4/2156 (0.19%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Skin and subcutaneous tissue disorders

Urticaria²

# participants affected / at risk

0/2156 (0.00%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Nausea²

# participants affected / at risk

4/2156 (0.19%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

Gastrointestinal disorders

Dry mouth²

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

1/886 (0.11%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Abdominal pain upper²

# participants affected / at risk

0/2156 (0.00%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

2/851 (0.24%)

Musculoskeletal and connective tissue disorders

Myalgia²

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Oesophagitis²

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Respiratory, thoracic and mediastinal disorders

Lung disorder²

# participants affected / at risk

0/2156 (0.00%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Ear and labyrinth disorders

Vertigo²

# participants affected / at risk

3/2156 (0.14%)

1/873 (0.11%)

1/886 (0.11%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Flatulence²

# participants affected / at risk

0/2156 (0.00%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

General disorders and administration site conditions

Asthenia²

# participants affected / at risk

0/2156 (0.00%)

2/873 (0.23%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Respiratory, thoracic and mediastinal disorders

Pharyngeal stenosis²

# participants affected / at risk

0/2156 (0.00%)

1/873 (0.11%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Skin and subcutaneous tissue disorders

Rash²

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

General disorders and administration site conditions

Somnolence²

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Metabolism and nutrition disorders

Weight decreased²

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Dysphagia²

# participants affected / at risk

1/2156 (0.05%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

0/851 (0.00%)

Gastrointestinal disorders

Gastrointestinal disorder²

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

2/851 (0.24%)

Gastrointestinal disorders

Gastroesophageal reflux disease²

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

Psychiatric disorders

Nervousness²

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

1/886 (0.11%)

0/880 (0.00%)

0/851 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Gastric cancer²

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

Musculoskeletal and connective tissue disorders

Intervertebral disc protrusion²

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

Gastrointestinal disorders

Gastric ulcer²

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

1/880 (0.11%)

0/851 (0.00%)

Respiratory, thoracic and mediastinal disorders

Cough²

# participants affected / at risk

0/2156 (0.00%)

0/873 (0.00%)

0/886 (0.00%)

0/880 (0.00%)

1/851 (0.12%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary, MedDRA (10.0)
3	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Planned number of patients not reached: statistical analysis plan revised,comparisons between treatment arms performed globally (No stratified analysis). Safety pop=3032-3 incorrect enrolments (withdrawals at V2) with no information on ttmt received

Results Point of Contact

Name/Title:	Gerard Lynch
Organization:	AstraZeneca
E-mail:	[email protected]

Documents available

AstraZeneca Clinical Trial Information – Outside US
Download
https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=435&filename=CSR-D9612L00111.pdf
Download
CSR-D9612L00111.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca France Clinical Study Information

+33 1 41 29 40 00

Investigators

Principal Investigator

AstraZeneca France Medical Director

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

AstraZeneca Clinical Trial Information – Outside US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=435&filename=CSR-D9612L00111.pdf

CSR-D9612L00111.pdf

Trial Results Summaries