Phase 3
N=340
Efficacy of Esomeprazole in Patients With Frequent Heartburn
Heartburn
Bottom Line
View on ClinicalTrials.gov: NCT01370525 ↗Enrolled (actual)
340
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment — 43.32; 29.44 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esomeprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment |
44.52; 31.25 | — |
| PRIMARY Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment |
44.52; 31.25 | — |
| SECONDARY Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period |
27; 7 | — |
| 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 |
64; 76; 25; 36; 36; 18 | — |
| SECONDARY Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment |
43; 17; 43; 16; 26; 10 | — |
Summary
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01370525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.