Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Procter and Gamble
• Treatments: ATI 7505

Criteria

Inclusion Criteria:

• written informed consent

• 18 and 75 years of age

• constipation symptom onset at least 6 months ago & meet ROME III criteria for chronic constipation

• negative colonoscopy or air contrast barium enema within the past 2 years if ≥50 years of age or within the past 5 years if <50 years of age;

• are able to refrain from use of medications known to treat constipation or associated symptoms throughout the study

Exclusion Criteria:

• transabdominal surgery, unstable coronary artery disease, organic gastrointestinal disease, collagen vascular disease, or any alarm symptoms within the 6 months prior to screening;

• taking prohibited medications (including laxatives, herbal remedies)

• participating in another drug or medical device study or use of any investigational drug within 30 days before dosing or planning to use prior to study completion;

• QTcB >440 msec, abnormal 12-lead ECG, family history of sudden death at age <40 years or history of long QT syndrome

• alcohol or drug abuse within the 6 months prior to screening;

• autonomic dyssynergic defecation