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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.

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Official Title

The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo (“inactive substance”) on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes.  Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.

Study to investigate the analgesic efficacy of a single dose of AZD1940

Research Site

A Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, in Patients Undergoing Impacted Mandibular Third Molar Extraction

Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.

Age Continuous

Gender, Customized

The analyses based on a per-protocol population.

Pain Area Under the Curve 0-8h (AUC0-8h)

Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.

Pain Area Under the VAS versus time curve 0-4h (AUC0-4h)

Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.

Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)

Maximum pain based on VAS scale

Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)

Mean pain based on a VAS scale

Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable)

The analyses based on a per-protocol pop.

Pain at jaw movement AUC0-8h

Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable).

Pain at jaw movement AUC0-4h

Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.

Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)

Maximum pain at jaw movement

Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ).

Mean pain at jaw movement

Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case.

Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable).

Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.

Pain at rescue medication

Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case.

Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable).

Pain at jaw movement at time of first rescue medication

Only patients actually taking rescue medication are included in analysis.

Time to first intake of rescue medication.

The analyses are based on a per-protocol population.

Number of patients requesting rescue medication

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from ‘not at all’ on the left end of the scale to ‘extremely’ on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry.

Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.

Maximum deterioration in Visual Analogue Mood Scale (VAMS) Stimulated

Maximum deterioration in VAMS High

Maximum deterioration in VAMS Anxious

Maximum deterioration in VAMS Sedated

Only patients reporting a deterioration are included. The analyses are based on a per-protocol population.

Arms	Assigned Interventions
Experimental: AZD1940 AZD1940 800ug given predose	Drug: AZD1940 800ug oral administration
Active Comparator: Naproxen Naproxen 500mg given pre-surgery	Drug: Naproxen 500mg oral administration Other Name: Naprosyn
Placebo Comparator: Placebo Placebo given pre-surgery	Drug: Placebo Placebo given pre-surgery

Study to investigate the analgesic efficacy of a single dose of AZD1940

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=311&filename=CSR-D3120C00006.pdf

CSR-D3120C00006.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator