NCT00501241

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
2 countries

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 17, 2009

Status Verified

February 1, 2008

Enrollment Period

1 year

First QC Date

July 12, 2007

Last Update Submit

June 16, 2009

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (1)

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

    7 days

Secondary Outcomes (1)

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

    daily and or weekly

Study Arms (5)

1

PLACEBO COMPARATOR

placebo twice daily

Drug: ATI-7505

2

EXPERIMENTAL

20 mg ATI-7505, BID for 4 weeks

Drug: ATI-7505

3

EXPERIMENTAL

40 mg ATI, BID, 4 weeks

Drug: ATI-7505

4

EXPERIMENTAL

80 mg ATI-4505, BID for 4 weeks

Drug: ATI-7505

5

EXPERIMENTAL

120 mg ATI-7505, BID for 4 weeks

Drug: ATI-7505

Interventions

ATI-7505DRUG

Tablet,placebo, BID

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Research Facility

Anaheim, California, United States

Location

Research facility

San Carlos, California, United States

Location

Research Facility

San Diego, California, United States

Location

Research Facility

Littleton, Colorado, United States

Location

Research Facility

Aventura, Florida, United States

Location

Research Facility

Hollywood, Florida, United States

Location

Research Facility

South Miami, Florida, United States

Location

Researrch Facility

Newnan, Georgia, United States

Location

Research Facility

Rockford, Illinois, United States

Location

Research Facility

Evansville, Indiana, United States

Location

Research Facility

Boston, Massachusetts, United States

Location

Research Facility

Great Neck, New York, United States

Location

Research Facility

Lake Success, New York, United States

Location

Research Facility

Cincinnati, Ohio, United States

Location

Research Facility

Oklahoma City, Oklahoma, United States

Location

Research Facility

Chattanooga, Tennessee, United States

Location

Research Facility

Nashville, Tennessee, United States

Location

Research Facility

Salt Lake City, Utah, United States

Location

Research Facility

Charlottesville, Virginia, United States

Location

Research Facility

Christiansburg, Virginia, United States

Location

Research Facility

Montreal, Quebec, Canada

Location

Reserach Facility

Québec, Quebec, Canada

Location

Research Facility

Saint Charles Borremee, Quebec, Canada

Location

MeSH Terms

Interventions

ATI 7505

Study Officials

  • Tom G Todaro, MD

    Procter and Gamble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 16, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 17, 2009

Record last verified: 2008-02

Locations

CA(3)US(20)