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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

This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Efficacy of Esomeprazole in Patients with Frequent Heartburn

Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

Research site

A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment with Esomeprazole 20 mg Once Daily in Subjects with Frequent Heartburn

Age Continuous

Gender, Male/Female

Randomized population was analyzed using criteria of white/ black or african american/ asian/ american indian or alaska native /white.

Race, Customized

Randomized population was analyzed using criteria of hispanic or latino/ not hispanic or latino/ not reported.

Ethnicity, Customized

Percentage of heartburn free 24 hour days during 14 days of randomized treatment

Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.

Number of subjects reporting heartburn 2 days or less during the 14 days randomized treatment period

Zero days

One day

Two days

Three days

Four days

The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.

Comparison of number of subjects with 0, 1, 2, 3 or 4 days with no heartburn over Days 1 to 4 between esomeprazole 20 mg and placebo

Last 7 consecutive days

Second 7 calender days

First 7 calendar days

There were three separate 7 day time periods during the treatment period;  The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6).  For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period.  However, for subjects reporting anything less than 14 days the two will not be identical.  For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.

Arms	Assigned Interventions
Experimental: Esomeprazole 20 mg	Drug: Esomeprazole Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Placebo Comparator: Placebo	Drug: Esomeprazole Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

Efficacy of Esomeprazole in Patients with Frequent Heartburn - NEXT1

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

CSR-D961RC00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator