Efficacy of Esomeprazole in Patients With Frequent Heartburn

Phase 3

Completed

• Conditions: Heartburn
• Interventions: Drug: Esomeprazole

• Registration Number: NCT01370538
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Study Start: 2011-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-10-19
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-01
• Last Update Submitted: 2013-03-01
• Results First Posted: 2013-04-11
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

• Males and non-pregnant ,non-lactating females 18 years or older
• Experience heartburn at least 2 days a week
• Having heartburn that has responded to heartburn medication
• Must discontinue any current heartburn medications

Exclusion Criteria

• Having a history of erosive esophagitis verified by endoscopy
• Having a history of GERD which was diagnosed by a physician
• Inability to take study medication or complete the study and all study procedures
• Subjects that have required more than one 14-day course of PPI treatment within the past 4 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esomeprazole 20 mg	Esomeprazole	-
Placebo	Esomeprazole	-

Primary Outcome Measures

Name	Time	Method
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment	From randomisation to day 14

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period	From randomisation to the day 14	Treatment period is considered to be both weeks 1 and 2 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	From randomisation to day 14	The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment	From randomisation to day 14	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.

Trial Locations

Locations (1)

Research site; 🇺🇸 West Jordan, Utah, United States