Efficacy of Esomeprazole in Patients With Frequent Heartburn

Heartburn Clinical Trial

— NEXT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370538
• Other study ID #: D961RC00002
• Status: Completed
• Phase: Phase 3
• First received: June 1, 2011
• Last updated: March 1, 2013
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heartburn

Intervention

Drug:
• Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

Locations

Country	Name	City	State
United States	Research site	Austin	Texas
United States	Research site	Dakota Dunes	South Dakota
United States	Research site	Lexington	Kentucky
United States	Research site	Mobile	Alabama
United States	Research site	Nashville	Tennessee
United States	Research site	Rochester	New York
United States	Research site	San Angelo	Texas
United States	Research site	San Francisco	California
United States	Research site	West Jordan	Utah
United States	Research site	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment		From randomisation to day 14	No
Secondary	Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period	Treatment period is considered to be both weeks 1 and 2 between V3 and V4.	From randomisation to the day 14	No
Secondary	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	The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.	From randomisation to day 14	No
Secondary	Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment	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.	From randomisation to day 14	No