Clinical trial NCT00501241: Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation
Official title: A Phase II, Randomized, Placebo-Controlled Study of ATI-7505 in Patients With Chronic Idiopathic Constipation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Constipation
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2007-07-16
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Total number of spontaneous bowel movements during the first 7 days after randomization
timeFrame: 7 days
Secondary outcomes:
measure: Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period
timeFrame: daily and or weekly
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Facility
state: California
city: San Carlos
country: United States
facility: Research facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: Littleton
country: United States
facility: Research Facility
state: Colorado
city: Aventura
country: United States
facility: Research Facility
state: Florida
city: Hollywood
country: United States
facility: Research Facility
state: Florida
city: South Miami
country: United States
facility: Research Facility
state: Florida
city: Newnan
country: United States
facility: Researrch Facility
state: Georgia
city: Rockford
country: United States
facility: Research Facility
state: Illinois
city: Evansville
country: United States
facility: Research Facility
state: Indiana
city: Boston
country: United States
facility: Research Facility
state: Massachusetts
city: Great Neck
country: United States
facility: Research Facility
state: New York
city: Lake Success
country: United States
facility: Research Facility
state: New York
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Oklahoma City
country: United States
facility: Research Facility
state: Oklahoma
city: Chattanooga
country: United States
facility: Research Facility
state: Tennessee
city: Nashville
country: United States
facility: Research Facility
state: Tennessee
city: Salt Lake City
country: United States
facility: Research Facility
state: Utah
city: Charlottesville
country: United States
facility: Research Facility
state: Virginia
city: Christiansburg
country: United States
facility: Research Facility
state: Virginia
city: Montreal
country: Canada
facility: Research Facility
state: Quebec
city: St. Charles Borremee
country: Canada
facility: Research Facility
state: Quebec
city: Quebec
country: Canada
facility: Reserach Facility
Study officials:
affiliation: Procter and Gamble
name: Tom G Todaro, MD
role: STUDY_DIRECTOR
References: