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

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00501241
• Other study ID #: 2007003
• 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

• Chronic Constipation
• Constipation

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