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

June 16, 2009 updated by: Procter and Gamble

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 1
placebo twice daily
Drug: ATI-7505
Tablet,placebo, BID
Drug: ATI-7505
ATI-7505 20 mg BID for 4 weeks
Drug: ATI-7505
tablet, 40 mg, BID, $ weeks
Drug: ATI-7505
80 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
120 mg ATI-7505, BID, for 4 weeks
Experimental: 2
20 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
Tablet,placebo, BID
Drug: ATI-7505
ATI-7505 20 mg BID for 4 weeks
Drug: ATI-7505
tablet, 40 mg, BID, $ weeks
Drug: ATI-7505
80 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
120 mg ATI-7505, BID, for 4 weeks
Experimental: 3
40 mg ATI, BID, 4 weeks
Drug: ATI-7505
Tablet,placebo, BID
Drug: ATI-7505
ATI-7505 20 mg BID for 4 weeks
Drug: ATI-7505
tablet, 40 mg, BID, $ weeks
Drug: ATI-7505
80 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
120 mg ATI-7505, BID, for 4 weeks
Experimental: 4
80 mg ATI-4505, BID for 4 weeks
Drug: ATI-7505
Tablet,placebo, BID
Drug: ATI-7505
ATI-7505 20 mg BID for 4 weeks
Drug: ATI-7505
tablet, 40 mg, BID, $ weeks
Drug: ATI-7505
80 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
120 mg ATI-7505, BID, for 4 weeks
Experimental: 5
120 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
Tablet,placebo, BID
Drug: ATI-7505
ATI-7505 20 mg BID for 4 weeks
Drug: ATI-7505
tablet, 40 mg, BID, $ weeks
Drug: ATI-7505
80 mg ATI-7505, BID for 4 weeks
Drug: ATI-7505
120 mg ATI-7505, BID, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Total number of spontaneous bowel movements during the first 7 days after randomization
Time Frame: 7 days
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Daily and/or weekly assessments of the consistency, severity, frequency, symptoms of constipation during the treatment period
Time Frame: daily and or weekly
daily and or weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Procter and Gamble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tom G Todaro, MD, Procter and Gamble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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