A Dose-Ranging Study of ATI 7505 in Patients With Postprandial Distress Syndrome

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Post Prandial Distress Syndrome

In brief

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 adequate relief of postprandial distress syndrome symptoms on at least 50% of the treatment days.

Key facts

Study ID

NCT00630370

Run by

Procter and Gamble

People needed

6

Starts

2008-02-01

Expected to finish

2008-07-01

Last updated by the study team

2009-06-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Facility — Fresno, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — Mission Viejo, California, United States
• Research Facility — San Carlos, California, United States
• Research Facility — San Diego, California, United States
• Research Facility — Littleton, Colorado, United States
• Research Facility — Boynton Beach, Florida, United States
• Research Facility — DeLand, Florida, United States
• Research Facility — Hollywood, Florida, United States
• Research Facility — Jacksonville, Florida, United States
• Research Facility — Largo, Florida, United States
• Research Facility — Miami, Florida, United States
• Research Facility — New Port Richey, Florida, United States
• Research Facility — Orlando, Florida, United States
• Research Facility — Newnan, Georgia, United States
• Research Facility — Savannah, Georgia, United States
• Research Facility — Rockford, Illinois, United States
• Research Facility — Evansville, Indiana, United States
• Research Facility — Topeka, Kansas, United States
• Research Facility — Monroe, Louisiana, United States
• Research Facility — Detroit, Michigan, United States
• Research Facility — Brooklyn, New York, United States
• Research Facility — Great Neck, New York, United States
• Research Facility — Chino, California, United States

Full record on ClinicalTrials.gov

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