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NCT01161602 Clinical Trial

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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01161602
Other study ID # Pumo-10-001
Secondary ID
Status Completed
Phase Phase 2
First received July 12, 2010
Last updated September 20, 2011
Est. completion date May 2011

Study information
Verified date September 2011
Source Edusa Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date May 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• Pumosetrag

• Pumosetrag

Other:
• Placebo

Drug:
• Pumosetrag

Locations
Country Name City State
United States Advanced Clinical Research Institute Anaheim California
United States Mayo Clinic Jacksonville Jacksonville Florida
United States Lynn Health Science Institute Oklahoma City Oklahoma
United States Mayo Clinic Rochester Rochester Minnesota
United States Mayo Clinic Scottsdale Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Edusa Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

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