Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Edusa Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01161602
First received: July 12, 2010
Last updated: September 20, 2011
Last verified: September 2011
  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
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, see Learn About Clinical Studies.

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
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on November 19, 2014