Back to resultsA Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pumosetrag
Pumosetrag
Placebo
Pumosetrag
Sponsored by
About this trial
This is an interventional trial for Gastroesophageal Reflux Disease focused on measuring Symptoms of Gastroesophageal Reflux Disease (GERD)
Eligibility 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.
Sites / Locations
- Mayo Clinic Scottsdale
- Advanced Clinical Research Institute
- Mayo Clinic Jacksonville
- Mayo Clinic Rochester
- Lynn Health Science Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
0.2mg Pumosetrag
0.5mg Pumosetrag
0.8mg Pumosetrag
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01161602
First Posted
July 12, 2010
Last Updated
September 20, 2011
Sponsor
Edusa Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01161602
Brief Title
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2011 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Edusa Pharmaceuticals, Inc.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Symptoms of Gastroesophageal Reflux Disease (GERD)
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
0.2mg Pumosetrag
Arm Type
Experimental
Arm Title
0.5mg Pumosetrag
Arm Type
Experimental
Arm Title
0.8mg Pumosetrag
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pumosetrag
Intervention Type
Drug
Intervention Name(s)
Pumosetrag
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Pumosetrag
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
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