Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

NCT ID: NCT00607971

Last Updated: 2008-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

939 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-06-30

Brief Summary

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The main purpose of this study is to evaluate the long-term safety and tolerability of renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C).

Detailed Description

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Since IBS is a chronic condition affecting patients over many years, it is anticipated that renzapride will be prescribed and used by patients on a daily basis for long periods of time. Hence the need to understand its long-term safety and tolerability in the target population. This study is open label and so all subjects will take renzapride and will know that they are taking it. Enrolment in to this study is restricted to subjects completing a 12-week, placebo-controlled study of the effectiveness of renzapride in providing relief from IBS-C (Study no. ATL1251/038/CL).

Conditions

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Constipation-Predominant Irritable Bowel Syndrome

Keywords

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Constipation predominant irritable bowel syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52

Group Type EXPERIMENTAL

Renzapride

Intervention Type DRUG

All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52

Interventions

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Renzapride

All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52

Intervention Type DRUG

Other Intervention Names

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ATL-1251 BRL 24924

Eligibility Criteria

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Inclusion Criteria

* completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL

Exclusion Criteria

* Subjects who are pregnant or breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alizyme

INDUSTRY

Sponsor Role lead

Responsible Party

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Alizyme Therapeutics Ltd

Principal Investigators

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Anthony Lembo, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center, Boston

Locations

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Huntsville, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Sierra Vista, Arizona, United States

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Little Rock, Arkansas, United States

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North Little Rock, Arkansas, United States

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Anaheim, California, United States

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Beverly Hills, California, United States

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Burbank, California, United States

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Carmichael, California, United States

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Cerritos, California, United States

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Chula Vista, California, United States

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Cypress, California, United States

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Laguna Hills, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Orange, California, United States

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San Carlos, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Colorado Springs, Colorado, United States

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Lakewood, Colorado, United States

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Littleton, Colorado, United States

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Bristol, Connecticut, United States

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Boynton Beach, Florida, United States

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Coral Gables, Florida, United States

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Gainesville, Florida, United States

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Hialeah, Florida, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Palm Harbor, Florida, United States

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Pembrook Pines, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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Port Orange, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Marietta, Georgia, United States

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Newnan, Georgia, United States

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Rockford, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Arkansas City, Kansas, United States

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Overland Park, Kansas, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Shreveport, Louisiana, United States

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Annapolis, Maryland, United States

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Hagerstown, Maryland, United States

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Laurel, Maryland, United States

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Pasadena, Maryland, United States

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Severna Park, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Chesterfield, Michigan, United States

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Kalamazoo, Michigan, United States

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Lansing, Michigan, United States

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Troy, Michigan, United States

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Tupelo, Mississippi, United States

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Mexico, Missouri, United States

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Springfield, Missouri, United States

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Scottsbluff, Nebraska, United States

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Cedar Knolls, New Jersey, United States

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Passaic, New Jersey, United States

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Sicklerville, New Jersey, United States

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Great Neck, New York, United States

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Great Neck, New York, United States

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Johnson City, New York, United States

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Kingston, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Elkin, North Carolina, United States

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Fayetteville, North Carolina, United States

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Greensboro, North Carolina, United States

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Greensboro, North Carolina, United States

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New Bern, North Carolina, United States

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Pinehurst, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Mogadore, Ohio, United States

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Sylvania, Ohio, United States

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Zanesville, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Downington, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Greer, South Carolina, United States

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Simpsonville, South Carolina, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Murray, Utah, United States

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Chesapeake, Virginia, United States

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Richmond, Virginia, United States

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Suffolk, Virginia, United States

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Virginia Beach, Virginia, United States

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Bellevue, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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ATL1251/052/CL

Identifier Type: -

Identifier Source: org_study_id