Trial | NCT01161602  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pumosetrag ...

  • Study Participants

    None
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 Started
Jul 12
2010
Study Completion
May 31
2011
Last Update
Sep 21
2011
Estimate

Drug Pumosetrag

Drug Pumosetrag

Other Placebo

Drug Pumosetrag

0.2mg Pumosetrag Experimental

0.5mg Pumosetrag Experimental

0.8mg Pumosetrag Experimental

Placebo Placebo Comparator

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.
No Results Posted