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
  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:


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
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, see Learn About Clinical Studies.

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 September 30, 2014