Phase 4
N=55
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
Heartburn
Bottom Line
View on ClinicalTrials.gov: NCT02708355 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn — 7; 10; 0; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Esomeprazole 20 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn |
7; 10; 0; 9; 8; 5 | — |
| PRIMARY Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4 |
12.53; 13.35; 12.32; 70.23; 42.83; 0.78 | 0.0442 sig |
Summary
The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.
Eligibility Criteria
Inclusion Criteria
- Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at least 3 months, while treating with gastric acid modulating therapy (antacids, H2 receptor antagonists (H2RAs) and/or PPIs).
- Heartburn symptoms that average 3 times per week or greater including at least 2 episodes of nighttime heartburn symptoms per week over the past 30 days.
- When heartburn medications were used, subject had heartburn symptoms that were responsive to antacids, non prescription H2RAs, or short term non prescription or prescription PPIs at approved doses but complete resolution of heartburn was not achieved.
Exclusion Criteria
- A history (past or present) of erosive esophagitis verified by endoscopy.
- The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (eg, long term prescription therapy).
- Subjects requiring continuous intervention by a physician for the treatment of GERD (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
Data sourced from ClinicalTrials.gov (NCT02708355). 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.