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

July 4, 2008 updated by: Alizyme

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)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

939

Phase

  • Phase 3

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

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Research Site
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Research Site
      • Phoenix, Arizona, United States, 85014
        • Research Site
      • Sierra Vista, Arizona, United States, 85635
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
      • North Little Rock, Arkansas, United States, 72117
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Beverley Hills, California, United States, 90211
        • Research Site
      • Burbank, California, United States, 91505
        • Research Site
      • Carmichael, California, United States, 95608
        • Research Site
      • Cerritos, California, United States, 90703
        • Research Site
      • Chula Vista, California, United States, 91910
        • Research Site
      • Cypress, California, United States, 90630
        • Research Site
      • Laguna Hills, California, United States, 92653
        • Research Site
      • Los Angeles, California, United States, 90045
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • Orange, California, United States, 92869
        • Research Site
      • San Carlos, California, United States, 94070
        • Research Site
      • San Diego, California, United States, 92123
        • Research Site
      • San Diego, California, United States, 92128
        • Research Site
      • San Francisco, California, United States, 94115
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Research Site
      • Lakewood, Colorado, United States, 80215
        • Research Site
      • Littleton, Colorado, United States, 80120
        • Research Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Research Site
      • Coral Gables, Florida, United States, 33134
        • Research Site
      • Gainesville, Florida, United States, 32607
        • Research Site
      • Hialeah, Florida, United States, 33013
        • Research Site
      • Inverness, Florida, United States, 34452
        • Research Site
      • Jacksonville, Florida, United States, 32207
        • Research Site
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • New Port Richey, Florida, United States, 34652
        • Research Site
      • Palm Harbor, Florida, United States, 34684
        • Research Site
      • Pembrook Pines, Florida, United States, 33024
        • Research Site
      • Pensacola, Florida, United States, 32514
        • Research Site
      • Plantation, Florida, United States, 33324
        • Research Site
      • Port Orange, Florida, United States, 32129
        • Research Site
      • Vero Beach, Florida, United States, 32960
        • Research Site
      • West Palm Beach, Florida, United States, 33409-3509
        • Research Site
    • Georgia
      • Marietta, Georgia, United States, 30067
        • Research Site
      • Newnan, Georgia, United States, 30263
        • Research Site
    • Illinois
      • Rockford, Illinois, United States, 61107-5078
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50321
        • Research Site
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Research Site
      • Overland Park, Kansas, United States, 66251
        • Research Site
      • Topeka, Kansas, United States, 66606
        • Research Site
      • Wichita, Kansas, United States, 67205
        • Research Site
      • Wichita, Kansas, United States, 67207
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Research Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Research Site
      • Hagerstown, Maryland, United States, 21740
        • Research Site
      • Laurel, Maryland, United States, 20707
        • Research Site
      • Pasadena, Maryland, United States, 21122
        • Research Site
      • Severna Park, Maryland, United States, 21146
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Research Site
      • Boston, Massachusetts, United States, 02215
        • Research Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Research Site
      • Kalamazoo, Michigan, United States, 49048
        • Research Site
      • Lansing, Michigan, United States, 48910
        • Research Site
      • Troy, Michigan, United States, 48098
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38802
        • Research Site
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Research Site
      • Springfield, Missouri, United States, 65807
        • Research Site
    • Nebraska
      • Scottsbluff, Nebraska, United States, 69361
        • Research Site
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 07927
        • Research Site
      • Passaic, New Jersey, United States, 07055
        • Research Site
      • Sicklerville, New Jersey, United States, 08090
        • Research Site
    • New York
      • Great Neck, New York, United States, 11021
        • Research Site
      • Great Neck, New York, United States, 11023
        • Research Site
      • Johnson City, New York, United States, 13790
        • Research Site
      • Kingston, New York, United States, 12401
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
      • New York, New York, United States, 10021
        • Research Site
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Research Site
      • Charlotte, North Carolina, United States, 28209
        • Research Site
      • Elkin, North Carolina, United States, 28621
        • Research Site
      • Fayetteville, North Carolina, United States, 28304
        • Research Site
      • Greensboro, North Carolina, United States, 27403
        • Research Site
      • Greensboro, North Carolina, United States, 27408
        • Research Site
      • New Bern, North Carolina, United States, 28562
        • Research Site
      • Pinehurst, North Carolina, United States, 28374
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
      • Wilmington, North Carolina, United States, 28412
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • North Dakota
      • Bismark, North Dakota, United States, 58501
        • Research Site
      • Fargo, North Dakota, United States, 58104
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Research Site
      • Columbus, Ohio, United States, 43215
        • Research Site
      • Mogadore, Ohio, United States, 44260
        • Research Site
      • Sylvania, Ohio, United States, 43560
        • Research Site
      • Zanesville, Ohio, United States, 43701
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Research Site
    • Pennsylvania
      • Downington, Pennsylvania, United States, 19335
        • Research Site
      • Lancaster, Pennsylvania, United States, 17604
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • Research Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Research Site
      • Simpsonville, South Carolina, United States, 29681
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Research Site
      • Chattanooga, Tennessee, United States, 37404
        • Research Site
      • Germantown, Tennessee, United States, 38138
        • Research Site
      • Jackson, Tennessee, United States, 38305
        • Research Site
      • Kingsport, Tennessee, United States, 37660
        • Research Site
      • Knoxville, Tennessee, United States, 37909
        • Research Site
      • Memphis, Tennessee, United States, 38120
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • Research Site
      • Corsicana, Texas, United States, 75110
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Dallas, Texas, United States, 75234
        • Research Site
      • FT. Worth, Texas, United States, 76104
        • Research Site
      • Houston, Texas, United States, 77090
        • Research Site
    • Utah
      • Murray, Utah, United States, 84107
        • Research Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Research Site
      • Richmond, Virginia, United States, 23294
        • Research Site
      • Suffolk, Virginia, United States, 23434
        • Research Site
      • Virginia Beach, Virginia, United States, 23454
        • Research Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Research Site
      • Spokane, Washington, United States, 99204
        • Research Site
      • Spokane, Washington, United States, 99207
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Research Site

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who are pregnant or breastfeeding

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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • ATL-1251
  • BRL 24924

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Vital signs, routine clinical laboratory data, 12-lead ECG
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Alizyme

Investigators

  • Principal Investigator: Anthony Lembo, MD, Beth Israel Deaconess Medical Center, Boston

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

April 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

July 8, 2008

Last Update Submitted That Met QC Criteria

July 4, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATL1251/052/CL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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