A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
This study has been completed.
Sponsor:
Edusa Pharmaceuticals, Inc.
Information provided by:
Edusa Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01161602
First received: July 12, 2010
Last updated: September 20, 2011
Last verified: September 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: Pumosetrag Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Edusa Pharmaceuticals, Inc.:
| Estimated Study Completion Date: | May 2011 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 0.2mg Pumosetrag | Drug: Pumosetrag |
| Experimental: 0.5mg Pumosetrag | Drug: Pumosetrag |
| Experimental: 0.8mg Pumosetrag | Drug: Pumosetrag |
| Placebo Comparator: Placebo | Other: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161602
Locations
| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| United States, Florida | |
| Mayo Clinic Jacksonville | |
| Jacksonville, Florida, United States | |
| United States, Minnesota | |
| Mayo Clinic Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Oklahoma | |
| Lynn Health Science Institute | |
| Oklahoma City, Oklahoma, United States, 73112 | |
Sponsors and Collaborators
Edusa Pharmaceuticals, Inc.
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01161602 History of Changes |
| Other Study ID Numbers: | Pumo-10-001 |
| Study First Received: | July 12, 2010 |
| Last Updated: | September 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Edusa Pharmaceuticals, Inc.:
|
Symptoms of Gastroesophageal Reflux Disease (GERD) |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013