A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Dose Levels of Pumosetrag in Patients With Symptoms Associated With Gastroesophageal Reflux Disease (GERD) Receiving a Standard Refluxogenic Meal
1 other identifier
interventional
N/A
1 country
5
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).
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2010
CompletedFirst Posted
Study publicly available on registry
July 13, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedSeptember 21, 2011
September 1, 2011
July 12, 2010
September 20, 2011
Conditions
Keywords
Study Arms (4)
0.2mg Pumosetrag
EXPERIMENTAL0.5mg Pumosetrag
EXPERIMENTAL0.8mg Pumosetrag
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant or lactating women.
- Allergic to pumosetrag or formulation excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 12, 2010
First Posted
July 13, 2010
Study Completion
May 1, 2011
Last Updated
September 21, 2011
Record last verified: 2011-09