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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01161602
Enrollment
Unknown
Registered
2010-07-13
Start date
Unknown
Completion date
2011-05-31
Last updated
2011-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

Symptoms of Gastroesophageal Reflux Disease (GERD)

Brief 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).

Interventions

DRUGPumosetrag
OTHERPlacebo

Sponsors

Edusa Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026