Overview

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.