- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161602
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
September 20, 2011 updated by: Edusa Pharmaceuticals, Inc.
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic Scottsdale
-
-
California
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Anaheim, California, United States, 92801
- Advanced Clinical Research Institute
-
-
Florida
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Jacksonville, Florida, United States
- Mayo Clinic Jacksonville
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
-
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Lynn Health Science Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: 0.2mg Pumosetrag
|
|
Experimental: 0.5mg Pumosetrag
|
|
Experimental: 0.8mg Pumosetrag
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
May 1, 2011
Study Registration Dates
First Submitted
July 12, 2010
First Submitted That Met QC Criteria
July 12, 2010
First Posted (Estimate)
July 13, 2010
Study Record Updates
Last Update Posted (Estimate)
September 21, 2011
Last Update Submitted That Met QC Criteria
September 20, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pumo-10-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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