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

Phase 2

Terminated

• Conditions: Chronic Constipation
• Interventions: Drug: ATI-7505

• Registration Number: NCT00501241
• Lead Sponsor: Procter and Gamble

Brief Summary

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

Detailed Description

This study is designed to evaluate the safety and efficacy of ATI 7505 in generally healthy, adult patients who have had symptoms of chronic idiopathic constipation for at least 6 months as defined in the ROME III criteria.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-12
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-16
• Status Verified: 2008-02
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Last Update Submitted: 2009-06-16
• Last Update Posted: 2009-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ATI-7505	placebo twice daily
2	ATI-7505	20 mg ATI-7505, BID for 4 weeks
3	ATI-7505	40 mg ATI, BID, 4 weeks
4	ATI-7505	80 mg ATI-4505, BID for 4 weeks
5	ATI-7505	120 mg ATI-7505, BID for 4 weeks

Primary Outcome Measures

Name	Time	Method
Total number of spontaneous bowel movements during the first 7 days after randomization	7 days

Secondary Outcome Measures

Name	Time	Method
Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period	daily and or weekly

Trial Locations

Locations (4)

Research facility; 🇺🇸 San Carlos, California, United States

Reserach Facility; 🇨🇦 Quebec, Canada

Research Facility; 🇨🇦 St. Charles Borremee, Quebec, Canada

Researrch Facility; 🇺🇸 Newnan, Georgia, United States