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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Constipation

In brief

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

Key facts

Study ID

NCT00501241

Run by

Procter and Gamble

People needed

214

Starts

2007-07-01

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…

• 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

You may not qualify if…

• 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

Where it is running

• Research Facility — Anaheim, 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 — Aventura, Florida, United States
• Research Facility — Hollywood, Florida, United States
• Research Facility — South Miami, Florida, United States
• Researrch Facility — Newnan, Georgia, United States
• Research Facility — Rockford, Illinois, United States
• Research Facility — Evansville, Indiana, United States
• Research Facility — Boston, Massachusetts, United States
• Research Facility — Great Neck, New York, United States
• Research Facility — Lake Success, New York, United States
• Research Facility — Cincinnati, Ohio, United States
• Research Facility — Oklahoma City, Oklahoma, United States
• Research Facility — Chattanooga, Tennessee, United States
• Research Facility — Nashville, Tennessee, United States
• Research Facility — Salt Lake City, Utah, United States
• Research Facility — Charlottesville, Virginia, United States
• Research Facility — Christiansburg, Virginia, United States
• Research Facility — Montreal, Quebec, Canada
• Reserach Facility — Québec, Quebec, Canada
• Research Facility — Saint Charles Borremee, Quebec, Canada

Full record on ClinicalTrials.gov

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