Heartburn Clinical Trial
— NEXT2Official 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
Verified date | March 2013 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States,
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 |
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