Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation
NCT ID: NCT00501241
Last Updated: 2009-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
214 participants
INTERVENTIONAL
2007-07-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
placebo twice daily
ATI-7505
Tablet,placebo, BID
2
20 mg ATI-7505, BID for 4 weeks
ATI-7505
ATI-7505 20 mg BID for 4 weeks
3
40 mg ATI, BID, 4 weeks
ATI-7505
tablet, 40 mg, BID, $ weeks
4
80 mg ATI-4505, BID for 4 weeks
ATI-7505
80 mg ATI-7505, BID for 4 weeks
5
120 mg ATI-7505, BID for 4 weeks
ATI-7505
120 mg ATI-7505, BID, for 4 weeks
Interventions
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ATI-7505
Tablet,placebo, BID
ATI-7505
ATI-7505 20 mg BID for 4 weeks
ATI-7505
tablet, 40 mg, BID, $ weeks
ATI-7505
80 mg ATI-7505, BID for 4 weeks
ATI-7505
120 mg ATI-7505, BID, for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Procter and Gamble Pharmaceuticals
Principal Investigators
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Tom G Todaro, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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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
Countries
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Other Identifiers
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2007003
Identifier Type: -
Identifier Source: org_study_id
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