Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
This study has been terminated.
(Terminated due to insufficient efficacy over placebo in Study ATL1251/038/CL.)
Sponsor:
Alizyme
Information provided by:
Alizyme
ClinicalTrials.gov Identifier:
NCT00607971
First received: January 23, 2008
Last updated: July 4, 2008
Last verified: July 2008
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation-Predominant Irritable Bowel Syndrome |
Drug: Renzapride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C) |
Resource links provided by NLM:
Further study details as provided by Alizyme:
Primary Outcome Measures:
- Adverse events [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Vital signs, routine clinical laboratory data, 12-lead ECG [ Time Frame: One year ] [ Designated as safety issue: No ]
| Enrollment: | 939 |
| Study Start Date: | April 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Drug: 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
Other Names:
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL
Exclusion Criteria:
- Subjects who are pregnant or breastfeeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607971
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| United States, Alabama | |
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| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
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| Chandler, Arizona, United States, 85225 | |
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| Phoenix, Arizona, United States, 85014 | |
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| Sierra Vista, Arizona, United States, 85635 | |
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| Little Rock, Arkansas, United States, 72205 | |
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| North Little Rock, Arkansas, United States, 72117 | |
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| Anaheim, California, United States, 92801 | |
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| Beverley Hills, California, United States, 90211 | |
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| Burbank, California, United States, 91505 | |
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| Carmichael, California, United States, 95608 | |
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| Cerritos, California, United States, 90703 | |
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| Chula Vista, California, United States, 91910 | |
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| Cypress, California, United States, 90630 | |
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| Laguna Hills, California, United States, 92653 | |
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| Los Angeles, California, United States, 90045 | |
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| San Carlos, California, United States, 94070 | |
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| Littleton, Colorado, United States, 80120 | |
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| Bristol, Connecticut, United States, 06010 | |
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| Boynton Beach, Florida, United States, 33426 | |
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| Coral Gables, Florida, United States, 33134 | |
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| Gainesville, Florida, United States, 32607 | |
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| Hialeah, Florida, United States, 33013 | |
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| Inverness, Florida, United States, 34452 | |
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| Jacksonville, Florida, United States, 32207 | |
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| Kissimmee, Florida, United States, 34741 | |
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| Pensacola, Florida, United States, 32514 | |
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| Port Orange, Florida, United States, 32129 | |
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| Vero Beach, Florida, United States, 32960 | |
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| West Palm Beach, Florida, United States, 33409-3509 | |
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| Marietta, Georgia, United States, 30067 | |
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| Newnan, Georgia, United States, 30263 | |
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| Rockford, Illinois, United States, 61107-5078 | |
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| Indianapolis, Indiana, United States, 46237 | |
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| Boston, Massachusetts, United States, 02114 | |
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| Chesterfield, Michigan, United States, 48047 | |
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| Scottsbluff, Nebraska, United States, 69361 | |
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| Cedar Knolls, New Jersey, United States, 07927 | |
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| Passaic, New Jersey, United States, 07055 | |
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| Sicklerville, New Jersey, United States, 08090 | |
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| Great Neck, New York, United States, 11023 | |
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| Great Neck, New York, United States, 11021 | |
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| Johnson City, New York, United States, 13790 | |
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| Kingston, New York, United States, 12401 | |
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| Mineola, New York, United States, 11501 | |
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| New York, New York, United States, 10021 | |
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| Burlington, North Carolina, United States, 27215 | |
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| Charlotte, North Carolina, United States, 28209 | |
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| Elkin, North Carolina, United States, 28621 | |
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| Fayetteville, North Carolina, United States, 28304 | |
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| Greensboro, North Carolina, United States, 27408 | |
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| Greensboro, North Carolina, United States, 27403 | |
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| New Bern, North Carolina, United States, 28562 | |
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| Pinehurst, North Carolina, United States, 28374 | |
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| Raleigh, North Carolina, United States, 27612 | |
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| Wilmington, North Carolina, United States, 28401 | |
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| Wilmington, North Carolina, United States, 28412 | |
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| Winston-Salem, North Carolina, United States, 27103 | |
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| Bismark, North Dakota, United States, 58501 | |
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| Fargo, North Dakota, United States, 58104 | |
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| Cincinnati, Ohio, United States, 45242 | |
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| Columbus, Ohio, United States, 43215 | |
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| Mogadore, Ohio, United States, 44260 | |
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| Sylvania, Ohio, United States, 43560 | |
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| Zanesville, Ohio, United States, 43701 | |
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| Norman, Oklahoma, United States, 73069 | |
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| Oklahoma City, Oklahoma, United States, 73112 | |
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| Downington, Pennsylvania, United States, 19335 | |
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| Lancaster, Pennsylvania, United States, 17604 | |
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| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, South Carolina | |
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| Greer, South Carolina, United States, 29651 | |
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| Simpsonville, South Carolina, United States, 29681 | |
| United States, Tennessee | |
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| Chattanooga, Tennessee, United States, 37403 | |
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| Chattanooga, Tennessee, United States, 37404 | |
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| Germantown, Tennessee, United States, 38138 | |
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| Jackson, Tennessee, United States, 38305 | |
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| Kingsport, Tennessee, United States, 37660 | |
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| Knoxville, Tennessee, United States, 37909 | |
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| Memphis, Tennessee, United States, 38120 | |
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| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
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| Austin, Texas, United States, 78745 | |
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| Corsicana, Texas, United States, 75110 | |
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| Dallas, Texas, United States, 75231 | |
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| Dallas, Texas, United States, 75234 | |
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| FT. Worth, Texas, United States, 76104 | |
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| Houston, Texas, United States, 77090 | |
| United States, Utah | |
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| Murray, Utah, United States, 84107 | |
| United States, Virginia | |
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| Chesapeake, Virginia, United States, 23320 | |
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| Richmond, Virginia, United States, 23294 | |
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| Suffolk, Virginia, United States, 23434 | |
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| Virginia Beach, Virginia, United States, 23454 | |
| United States, Washington | |
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| Bellevue, Washington, United States, 98004 | |
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| Spokane, Washington, United States, 99204 | |
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| Spokane, Washington, United States, 99207 | |
| United States, Wisconsin | |
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| Milwaukee, Wisconsin, United States, 53215 | |
Sponsors and Collaborators
Alizyme
Investigators
| Principal Investigator: | Anthony Lembo, MD | Beth Israel Deaconess Medical Center, Boston |
More Information
No publications provided
| Responsible Party: | Research & Development Director, Alizyme Therapeutics Ltd |
| ClinicalTrials.gov Identifier: | NCT00607971 History of Changes |
| Other Study ID Numbers: | ATL1251/052/CL |
| Study First Received: | January 23, 2008 |
| Last Updated: | July 4, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alizyme:
|
Constipation predominant irritable bowel syndrome |
Additional relevant MeSH terms:
|
Constipation Irritable Bowel Syndrome Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Renzapride Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013