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

Primary Purpose

Chronic Constipation

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ATI-7505
ATI-7505
ATI-7505
ATI-7505
ATI-7505
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Facility
  • Research facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Researrch Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Reserach Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

Arm Description

placebo twice daily

20 mg ATI-7505, BID for 4 weeks

40 mg ATI, BID, 4 weeks

80 mg ATI-4505, BID for 4 weeks

120 mg ATI-7505, BID for 4 weeks

Outcomes

Primary Outcome Measures

Total number of spontaneous bowel movements during the first 7 days after randomization

Secondary Outcome Measures

Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period

Full Information

First Posted
July 12, 2007
Last Updated
June 16, 2009
Sponsor
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT00501241
Brief Title
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

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Terminated
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Procter and Gamble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo twice daily
Arm Title
2
Arm Type
Experimental
Arm Description
20 mg ATI-7505, BID for 4 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
40 mg ATI, BID, 4 weeks
Arm Title
4
Arm Type
Experimental
Arm Description
80 mg ATI-4505, BID for 4 weeks
Arm Title
5
Arm Type
Experimental
Arm Description
120 mg ATI-7505, BID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ATI-7505
Intervention Description
Tablet,placebo, BID
Intervention Type
Drug
Intervention Name(s)
ATI-7505
Intervention Description
ATI-7505 20 mg BID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ATI-7505
Intervention Description
tablet, 40 mg, BID, $ weeks
Intervention Type
Drug
Intervention Name(s)
ATI-7505
Intervention Description
80 mg ATI-7505, BID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ATI-7505
Intervention Description
120 mg ATI-7505, BID, for 4 weeks
Primary Outcome Measure Information:
Title
Total number of spontaneous bowel movements during the first 7 days after randomization
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period
Time Frame
daily and or weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom G Todaro, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research facility
City
San Carlos
State/Province
California
Country
United States
Facility Name
Research Facility
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Facility
City
Littleton
State/Province
Colorado
Country
United States
Facility Name
Research Facility
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Research Facility
City
Hollywood
State/Province
Florida
Country
United States
Facility Name
Research Facility
City
South Miami
State/Province
Florida
Country
United States
Facility Name
Researrch Facility
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
Research Facility
City
Rockford
State/Province
Illinois
Country
United States
Facility Name
Research Facility
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Research Facility
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Research Facility
City
Great Neck
State/Province
New York
Country
United States
Facility Name
Research Facility
City
Lake Success
State/Province
New York
Country
United States
Facility Name
Research Facility
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Facility
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Facility
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Research Facility
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Research Facility
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Research Facility
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Research Facility
City
Christiansburg
State/Province
Virginia
Country
United States
Facility Name
Research Facility
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Facility
City
St. Charles Borremee
State/Province
Quebec
Country
Canada
Facility Name
Reserach Facility
City
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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