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A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161602
First Posted: July 13, 2010
Last Update Posted: September 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Edusa Pharmaceuticals, Inc.
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT01161602     History of Changes
Other Study ID Numbers: Pumo-10-001
First Submitted: July 12, 2010
First Posted: July 13, 2010
Last Update Posted: September 21, 2011
Last Verified: September 2011

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