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:
Information provided by:
Alizyme
ClinicalTrials.gov Identifier:
NCT00607971
First received: January 23, 2008
Last updated: July 4, 2008
Last verified: July 2008

January 23, 2008
July 4, 2008
April 2006
June 2008   (final data collection date for primary outcome measure)
Adverse events [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00607971 on ClinicalTrials.gov Archive Site
Vital signs, routine clinical laboratory data, 12-lead ECG [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
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).

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).

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Constipation-Predominant Irritable Bowel Syndrome
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
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
Intervention: Drug: Renzapride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
939
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who are pregnant or breastfeeding
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00607971
ATL1251/052/CL
Yes
Research & Development Director, Alizyme Therapeutics Ltd
Alizyme
Not Provided
Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center, Boston
Alizyme
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP