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

June 16, 2009 updated by: Procter and Gamble

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

214

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Reserach Facility
    • Quebec
      • Montreal, Quebec, Canada
        • Research Facility
      • St. Charles Borremee, Quebec, Canada
        • Research Facility
  • United States
    • California
      • Anaheim, California, United States
        • Research Facility
      • San Carlos, California, United States
        • Research Facility
      • San Diego, California, United States
        • Research Facility
    • Colorado
      • Littleton, Colorado, United States
        • Research Facility
    • Florida
      • Aventura, Florida, United States
        • Research Facility
      • Hollywood, Florida, United States
        • Research Facility
      • South Miami, Florida, United States
        • Research Facility
    • Georgia
      • Newnan, Georgia, United States
        • Researrch Facility
    • Illinois
      • Rockford, Illinois, United States
        • Research Facility
    • Indiana
      • Evansville, Indiana, United States
        • Research Facility
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Facility
    • New York
      • Great Neck, New York, United States
        • Research Facility
      • Lake Success, New York, United States
        • Research Facility
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Facility
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Facility
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Facility
      • Nashville, Tennessee, United States
        • Research Facility
    • Utah
      • Salt Lake City, Utah, United States
        • Research Facility
    • Virginia
      • Charlottesville, Virginia, United States
        • Research Facility
      • Christiansburg, Virginia, United States
        • Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
placebo twice daily
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
Experimental: 2
20 mg ATI-7505, BID for 4 weeks
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
Experimental: 3
40 mg ATI, BID, 4 weeks
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
Experimental: 4
80 mg ATI-4505, BID for 4 weeks
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
Experimental: 5
120 mg ATI-7505, BID for 4 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of spontaneous bowel movements during the first 7 days after randomization
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period
Time Frame: daily and or weekly
daily and or weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Investigators

  • Study Director: Tom G Todaro, MD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

July 12, 2007

First Submitted That Met QC Criteria

July 12, 2007

First Posted (Estimate)

July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

June 17, 2009

Last Update Submitted That Met QC Criteria

June 16, 2009

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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