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

Edusa Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Pumosetrag; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01161602

Pumo-10-001

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 4 patient groups, including a placebo group

0.2mg Pumosetrag

Experimental group

Treatment:

Drug: Pumosetrag

Drug: Pumosetrag

Drug: Pumosetrag

0.5mg Pumosetrag

Experimental group

Treatment:

Drug: Pumosetrag

Drug: Pumosetrag

Drug: Pumosetrag

0.8mg Pumosetrag

Experimental group

Treatment:

Drug: Pumosetrag

Drug: Pumosetrag

Drug: Pumosetrag

Placebo

Placebo Comparator group

Treatment:

Other: Placebo