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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

July 12, 2007
June 16, 2009
July 2007
July 2008   (final data collection date for primary outcome measure)
Total number of spontaneous bowel movements during the first 7 days after randomization [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Total number of spontaneous bowel movements during the first 7 days after randomization [ Time Frame: 7 days ]
Complete list of historical versions of study NCT00501241 on ClinicalTrials.gov Archive Site
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 ]
Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period [ Time Frame: daily and or weekly ]
Not Provided
Not Provided
 
Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation
A Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation

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

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Constipation
  • Drug: ATI-7505
    Tablet,placebo, BID
  • Drug: ATI-7505
    ATI-7505 20 mg BID for 4 weeks
  • Drug: ATI-7505
    tablet, 40 mg, BID, $ weeks
  • Drug: ATI-7505
    80 mg ATI-7505, BID for 4 weeks
  • Drug: ATI-7505
    120 mg ATI-7505, BID, for 4 weeks
  • Placebo Comparator: 1
    placebo twice daily
    Intervention: Drug: ATI-7505
  • Experimental: 2
    20 mg ATI-7505, BID for 4 weeks
    Intervention: Drug: ATI-7505
  • Experimental: 3
    40 mg ATI, BID, 4 weeks
    Intervention: Drug: ATI-7505
  • Experimental: 4
    80 mg ATI-4505, BID for 4 weeks
    Intervention: Drug: ATI-7505
  • Experimental: 5
    120 mg ATI-7505, BID for 4 weeks
    Intervention: Drug: ATI-7505
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
214
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00501241
2007003
No
Tom Todaro, MD, Procter and Gamble Pharmaceuticals
Procter and Gamble
Not Provided
Study Director: Tom G Todaro, MD Procter and Gamble
Procter and Gamble
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP