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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501241
First Posted: July 16, 2007
Last Update Posted: June 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Procter and Gamble
  Purpose
The purpose of this study is to determine whether ATI-7505 is effective in the treatment of chronic idiopathic constipation.

Condition Intervention Phase
Chronic Constipation Drug: ATI-7505 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Total number of spontaneous bowel movements during the first 7 days after randomization [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period [ Time Frame: daily and or weekly ]

Estimated Enrollment: 214
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
placebo twice daily
Drug: ATI-7505
Tablet,placebo, BID
Experimental: 2
20 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
ATI-7505 20 mg BID for 4 weeks
Experimental: 3
40 mg ATI, BID, 4 weeks
Drug: ATI-7505
tablet, 40 mg, BID, $ weeks
Experimental: 4
80 mg ATI-4505, BID for 4 weeks
Drug: ATI-7505
80 mg ATI-7505, BID for 4 weeks
Experimental: 5
120 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
120 mg ATI-7505, BID, for 4 weeks

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501241


  Hide Study Locations
Locations
United States, California
Research Facility
Anaheim, California, United States
Research facility
San Carlos, California, United States
Research Facility
San Diego, California, United States
United States, Colorado
Research Facility
Littleton, Colorado, United States
United States, Florida
Research Facility
Aventura, Florida, United States
Research Facility
Hollywood, Florida, United States
Research Facility
South Miami, Florida, United States
United States, Georgia
Researrch Facility
Newnan, Georgia, United States
United States, Illinois
Research Facility
Rockford, Illinois, United States
United States, Indiana
Research Facility
Evansville, Indiana, United States
United States, Massachusetts
Research Facility
Boston, Massachusetts, United States
United States, New York
Research Facility
Great Neck, New York, United States
Research Facility
Lake Success, New York, United States
United States, Ohio
Research Facility
Cincinnati, Ohio, United States
United States, Oklahoma
Research Facility
Oklahoma City, Oklahoma, United States
United States, Tennessee
Research Facility
Chattanooga, Tennessee, United States
Research Facility
Nashville, Tennessee, United States
United States, Utah
Research Facility
Salt Lake City, Utah, United States
United States, Virginia
Research Facility
Charlottesville, Virginia, United States
Research Facility
Christiansburg, Virginia, United States
Canada, Quebec
Research Facility
Montreal, Quebec, Canada
Research Facility
St. Charles Borremee, Quebec, Canada
Canada
Reserach Facility
Quebec, Canada
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Tom G Todaro, MD Procter and Gamble
  More Information

Responsible Party: Tom Todaro, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00501241     History of Changes
Other Study ID Numbers: 2007003
First Submitted: July 12, 2007
First Posted: July 16, 2007
Last Update Posted: June 17, 2009
Last Verified: February 2008

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
ATI 7505
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs