An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients with Symptoms of Gastroesophageal Reflux Disease (GERD)

Study identifier:D9612L00083

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients with Symptoms of Gastroesophageal Reflux Disease (GERD) to Investigate the Relationship between the Presence of Erosive Esophagitis (EE) at Baseline and Heartburn Resolution after 4 Weeks of Treatment

Medical condition

GERD

Phase

Phase 4

Healthy volunteers

Study drug

Esomeprazole

Sex

All

Actual Enrollment

350

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 Oct 2005

Primary Completion Date: -

Study Completion Date: 01 Jan 2006

Study design

Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Symptoms of GERD as defined in this protocol: Heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the Screening visit (Visit 1) and, on average, at least 2 times per week over the past 3 months.
- Male or female, 18 to 70 years old, inclusive.
- Non-pregnant, non-lactating female patients. Female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. Females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.
- Negative urine pregnancy test for females of childbearing potential.
- Willingness to adhere to all protocol requirements.

Exclusion Criteria

- Previous enrollment in the present study.
- Significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study.
- Use of a PPI, including PRILOSEC OTC®, within 21 days of Screening (Visit 1) or at anytime during the study (Visit 1 through Visit 4).
- Daily therapy with an H2 RA within 14 days of Screening (Visit 1): eg, ranitidine (ZANTAC®), cimetidine (TAGAMET®), nizatidine (AXID®), famotidine (PEPCID®) (occasional use; ie, less than daily, is permitted).
- Use of H2 RAs at any frequency are prohibited throughout the entire study (Visit 1 through Visit 4).
- A history of gastric or esophageal surgery (including, but not limited to, Nissen fundoplication and bariatric surgery), except for simple closure of a perforated ulcer or procedures that would not affect the study as determined by the Clinical Study Team physician at AstraZeneca.
- Clinically significant gastrointestinal (GI) bleeding (eg, melena, frank hematochezia) within 3 days of Screening (Visit 1) or noted at the time of baseline EGD.
- Non-acid related etiologies of esophagitis (eg, pill-induced, caustic ingestion or eosinophilic esophagitis).
Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).

No locations available

Arms	Assigned Interventions

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=664&filename=CSR-D9612L00083.pdf
Download
CSR-D9612L00083.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Information, (US - 8a-7p EST)

800-236-9933

http://[email protected]

Investigators

Principal Investigator

AstraZeneca Nexium Medical Sciences Director

AstraZeneca