Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Esomeprazole; Proton Pump Inhibitors

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).