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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:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00501241
First received: July 12, 2007
Last updated: June 16, 2009
Last verified: February 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Constipation
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501241

  Show 23 Study Locations
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Tom G Todaro, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Tom Todaro, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00501241     History of Changes
Other Study ID Numbers: 2007003
Study First Received: July 12, 2007
Last Updated: June 16, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013