CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
Esomeprazole 20 mg +1 moredrug
Likely dose
Esomeprazole 20 mg once daily for 14 daysAI-extracted
Key inclusion· 3
  • ✓Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain lasting at least 3 months while on gastric acid modulating therapy (antacids, H2RAs, and/or PPIs).
  • ✓Heartburn symptoms averaging ≥3 times per week, with at least 2 episodes of nighttime heartburn per week over the past 30 days.
  • ✓Heartburn symptoms responsive to antacids, non-prescription H2RAs, or short-term PPIs at approved doses, but with incomplete symptom resolution.
Key exclusion· 3
  • ✕History (past or present) of erosive esophagitis verified by endoscopy.
  • ✕Need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or antacids for any indication through the study (e.g., long-term prescription therapy).
  • ✕Subjects requiring continuous physician intervention for GERD treatment, including treatment of erosive esophagitis or prevention of relapse of healed esophagitis.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02708355
NCT02708355Phase 4Completed
CompareCT.gov

A Pilot Phase IV, Multicenter, Randomized, Double Blind, Placebo-Controlled, Parallel Study To Investigate The Correlation Between Ph Control And Heartburn Symptoms After 14 Days Of Proton Pump Inhibitor Treatment In Subjects With Frequent Heartburn

Pfizer·interventional·Posted Mar 15, 2016·Updated Apr 19, 2017

In Brief

A Phase 4 clinical trial evaluating Esomeprazole 20 mg and Placebo for Heartburn. Completed, enrolled 55 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeartburn
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 15, 2016
Enrollment StartJan 1, 2016
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.3 years ago

Interventions

Esomeprazole 20 mgdrug

Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)

Placebodrug

Placebo capsules