A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
Phase 2
Completed
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Other: Placebo
- Registration Number
- NCT01161602
- Lead Sponsor
- Edusa Pharmaceuticals, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 0.5mg Pumosetrag Pumosetrag - 0.8mg Pumosetrag Pumosetrag - Placebo Placebo - 0.2mg Pumosetrag Pumosetrag -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States