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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00501241
Other study ID # 2007003
Secondary ID
Status Terminated
Phase Phase 2
First received July 12, 2007
Last updated June 16, 2009
Start date July 2007
Est. completion date July 2008

Study information

Verified date February 2008
Source Procter and Gamble
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 214
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ATI-7505
Tablet,placebo, BID
ATI-7505
ATI-7505 20 mg BID for 4 weeks
ATI-7505
tablet, 40 mg, BID, $ weeks
ATI-7505
80 mg ATI-7505, BID for 4 weeks
ATI-7505
120 mg ATI-7505, BID, for 4 weeks

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Procter and Gamble

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total number of spontaneous bowel movements during the first 7 days after randomization 7 days No
Secondary Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period daily and or weekly No
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