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

NCT00607971 | Terminated Phase 3 DMC

• 1 other identifier: ATL1251/052/CL
• Study Type: interventional
• Target: 939
• Locations: 1 country
• Sites: 126

Brief Summary

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).

Conditions

Constipation-Predominant Irritable Bowel Syndrome

Keywords

Constipation predominant irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

• Adverse events

  One year

Secondary Outcomes (1)

• Vital signs, routine clinical laboratory data, 12-lead ECG

  One year

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Renzapride

Interventions

Renzapride 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

Also known as: ATL-1251, BRL 24924

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who are pregnant or breastfeeding

Sponsors & Collaborators

• Alizyme: lead

Study Sites (126)

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Huntsville, Alabama, 35801, United States

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Chandler, Arizona, 85225, United States

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Phoenix, Arizona, 85014, United States

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Sierra Vista, Arizona, 85635, United States

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Little Rock, Arkansas, 72205, United States

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North Little Rock, Arkansas, 72117, United States

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Anaheim, California, 92801, United States

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Beverly Hills, California, 90211, United States

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Burbank, California, 91505, United States

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Carmichael, California, 95608, United States

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Cerritos, California, 90703, United States

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Chula Vista, California, 91910, United States

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Cypress, California, 90630, United States

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Laguna Hills, California, 92653, United States

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Los Angeles, California, 90045, United States

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Orange, California, 92868, United States

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Orange, California, 92869, United States

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San Carlos, California, 94070, United States

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San Diego, California, 92123, United States

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San Diego, California, 92128, United States

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San Francisco, California, 94115, United States

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Colorado Springs, Colorado, 80904, United States

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Lakewood, Colorado, 80215, United States

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Littleton, Colorado, 80120, United States

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Bristol, Connecticut, 06010, United States

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Boynton Beach, Florida, 33426, United States

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Coral Gables, Florida, 33134, United States

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Gainesville, Florida, 32607, United States

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Hialeah, Florida, 33013, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32207, United States

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Jacksonville, Florida, 32256, United States

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Kissimmee, Florida, 34741, United States

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Miami, Florida, 33173, United States

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New Port Richey, Florida, 34652, United States

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Palm Harbor, Florida, 34684, United States

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Pembrook Pines, Florida, 33024, United States

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Pensacola, Florida, 32514, United States

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Plantation, Florida, 33324, United States

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Port Orange, Florida, 32129, United States

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Vero Beach, Florida, 32960, United States

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West Palm Beach, Florida, 33409-3509, United States

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Marietta, Georgia, 30067, United States

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Newnan, Georgia, 30263, United States

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Rockford, Illinois, 61107-5078, United States

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Indianapolis, Indiana, 46237, United States

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Des Moines, Iowa, 50321, United States

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Arkansas City, Kansas, 67005, United States

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Overland Park, Kansas, 66251, United States

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Topeka, Kansas, 66606, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Shreveport, Louisiana, 71103, United States

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Annapolis, Maryland, 21401, United States

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Hagerstown, Maryland, 21740, United States

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Laurel, Maryland, 20707, United States

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Pasadena, Maryland, 21122, United States

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Severna Park, Maryland, 21146, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02215, United States

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Chesterfield, Michigan, 48047, United States

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Kalamazoo, Michigan, 49048, United States

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Lansing, Michigan, 48910, United States

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Troy, Michigan, 48098, United States

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Tupelo, Mississippi, 38802, United States

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Mexico, Missouri, 65265, United States

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Springfield, Missouri, 65807, United States

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Scottsbluff, Nebraska, 69361, United States

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Cedar Knolls, New Jersey, 07927, United States

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Passaic, New Jersey, 07055, United States

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Sicklerville, New Jersey, 08090, United States

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Great Neck, New York, 11021, United States

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Great Neck, New York, 11023, United States

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Johnson City, New York, 13790, United States

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Kingston, New York, 12401, United States

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Mineola, New York, 11501, United States

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New York, New York, 10021, United States

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Burlington, North Carolina, 27215, United States

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Charlotte, North Carolina, 28209, United States

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Elkin, North Carolina, 28621, United States

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Fayetteville, North Carolina, 28304, United States

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Greensboro, North Carolina, 27403, United States

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Greensboro, North Carolina, 27408, United States

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New Bern, North Carolina, 28562, United States

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Pinehurst, North Carolina, 28374, United States

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Raleigh, North Carolina, 27612, United States

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Wilmington, North Carolina, 28401, United States

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Wilmington, North Carolina, 28412, United States

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Winston-Salem, North Carolina, 27103, United States

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Bismarck, North Dakota, 58501, United States

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Fargo, North Dakota, 58104, United States

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Cincinnati, Ohio, 45242, United States

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Columbus, Ohio, 43215, United States

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Mogadore, Ohio, 44260, United States

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Sylvania, Ohio, 43560, United States

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Zanesville, Ohio, 43701, United States

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Norman, Oklahoma, 73069, United States

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Oklahoma City, Oklahoma, 73112, United States

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Downington, Pennsylvania, 19335, United States

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Lancaster, Pennsylvania, 17604, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Greer, South Carolina, 29651, United States

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Simpsonville, South Carolina, 29681, United States

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Chattanooga, Tennessee, 37403, United States

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Chattanooga, Tennessee, 37404, United States

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Germantown, Tennessee, 38138, United States

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Jackson, Tennessee, 38305, United States

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Kingsport, Tennessee, 37660, United States

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Knoxville, Tennessee, 37909, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78745, United States

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Corsicana, Texas, 75110, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75234, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77090, United States

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Murray, Utah, 84107, United States

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Chesapeake, Virginia, 23320, United States

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Richmond, Virginia, 23294, United States

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Suffolk, Virginia, 23434, United States

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Virginia Beach, Virginia, 23454, United States

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Bellevue, Washington, 98004, United States

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Spokane, Washington, 99204, United States

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Spokane, Washington, 99207, United States

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Milwaukee, Wisconsin, 53215, United States

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MeSH Terms

Interventions

renzapride

Study Officials

• Anthony Lembo, MD

  Beth Israel Deaconess Medical Center, Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Study Start: April 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 8, 2008

Record last verified: 2008-07

Locations

US (126)