A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if pumosetrag is effective in treating Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD symptoms and are currently taking an acid suppression therapy, such as a Proton Pump Inhibitor (PPI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edusa Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Patients with history of Gastroesophageal Reflux Disease (GERD) symptoms (heartburn, regurgitation, acid taste in mouth).

• Between ages of 18 - 70 inclusive.

• Develop GERD symptoms following ingestion of a refluxogenic meal.

• Able to take a stable Proton Pump Inhibitor (PPI) regimen for duration of study.

• Understand and sign the informed consent form.

Exclusion Criteria:

• Pregnant or lactating women.

• Allergic to pumosetrag or formulation excipients.