Status:
TERMINATED
A Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome
Lead Sponsor:
Procter and Gamble
Collaborating Sponsors:
ARYx Therapeutics
Conditions:
Post Prandial Distress Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To assess the efficacy of 3 oral dosing regimens of ATI 7505 compared to placebo in patients with PDS by comparing at the end of Day 42 the percentage of patients in each treatment group who have had ...
Eligibility Criteria
Inclusion
- Were diagnosed with PDS at least 6 months prior to screening, OR had onset of 2 or more PDS symptoms at least 6 months prior to screening.
- Experienced early satiety or bothersome postprandial fullness repeatedly during the 3 months prior to screening.
- Had a normal upper GI endoscopy within the past year.
Exclusion
- Heartburn that occurs \>3 times per week
- Current Helicobacter pylori (H pylori) infection confirmed by stool sample testing or breath testing, or H pylori eradication therapy within the 6 months prior to screening
- Any alarm symptoms including uninvestigated anemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening
- At screening, a QT interval corrected for heart rate using Bazett's correction formula (QTcB) \>440 msec as determined by the Investigator.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00630370
Start Date
February 1 2008
End Date
July 1 2008
Last Update
June 17 2009
Active Locations (64)
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1
Research Facility
Chino, California, United States, 91710
2
Research Facility
Fresno, California, United States, 93721
3
Research Facility
Los Angeles, California, United States, 90015
4
Research Facility
Los Angeles, California, United States, 90045