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

Constipation-Predominant Irritable Bowel Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00607971
• Other study ID #: ATL1251/052/CL
• Status: Terminated
• Phase: Phase 3
• First received: January 23, 2008
• Last updated: July 4, 2008
• Start date: April 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Alizyme
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 939
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Subjects who are pregnant or breastfeeding

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Constipation
• Constipation-Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Research Site	Anaheim	California
United States	Research Site	Annapolis	Maryland
United States	Research Site	Arkansas City	Kansas
United States	Research Site	Austin	Texas
United States	Research Site	Bellevue	Washington
United States	Research Site	Beverley Hills	California
United States	Research Site	Bismark	North Dakota
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Bristol	Connecticut
United States	Research Site	Burbank	California
United States	Research Site	Burlington	North Carolina
United States	Research Site	Carmichael	California
United States	Research Site	Cedar Knolls	New Jersey
United States	Research Site	Cerritos	California
United States	Research Site	Chandler	Arizona
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Chesterfield	Michigan
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbus	Ohio
United States	Research Site	Coral Gables	Florida
United States	Research Site	Corsicana	Texas
United States	Research Site	Cypress	California
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Des Moines	Iowa
United States	Research Site	Downington	Pennsylvania
United States	Research Site	Elkin	North Carolina
United States	Research Site	Fargo	North Dakota
United States	Research Site	Fayetteville	North Carolina
United States	Research Site	FT. Worth	Texas
United States	Research Site	Gainesville	Florida
United States	Research Site	Germantown	Tennessee
United States	Research Site	Great Neck	New York
United States	Research Site	Great Neck	New York
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Greer	South Carolina
United States	Research Site	Hagerstown	Maryland
United States	Research Site	Hialeah	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Inverness	Florida
United States	Research Site	Jackson	Tennessee
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Johnson City	New York
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Kingsport	Tennessee
United States	Research Site	Kingston	New York
United States	Research Site	Kissimmee	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Laguna Hills	California
United States	Research Site	Lakewood	Colorado
United States	Research Site	Lancaster	Pennsylvania
United States	Research Site	Lansing	Michigan
United States	Research Site	Laurel	Maryland
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Littleton	Colorado
United States	Research Site	Los Angeles	California
United States	Research Site	Marietta	Georgia
United States	Research Site	Memphis	Tennessee
United States	Research Site	Mexico	Missouri
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Mineola	New York
United States	Research Site	Mogadore	Ohio
United States	Research Site	Murray	Utah
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Bern	North Carolina
United States	Research Site	New Port Richey	Florida
United States	Research Site	New York	New York
United States	Research Site	Newnan	Georgia
United States	Research Site	Norman	Oklahoma
United States	Research Site	North Little Rock	Arkansas
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Orange	California
United States	Research Site	Overland Park	Kansas
United States	Research Site	Palm Harbor	Florida
United States	Research Site	Pasadena	Maryland
United States	Research Site	Passaic	New Jersey
United States	Research Site	Pembrook Pines	Florida
United States	Research Site	Pensacola	Florida
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pinehurst	North Carolina
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plantation	Florida
United States	Research Site	Port Orange	Florida
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Richmond	Virginia
United States	Research Site	Rockford	Illinois
United States	Research Site	San Carlos	California
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	San Francisco	California
United States	Research Site	Scottsbluff	Nebraska
United States	Research Site	Severna Park	Maryland
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Sicklerville	New Jersey
United States	Research Site	Sierra Vista	Arizona
United States	Research Site	Simpsonville	South Carolina
United States	Research Site	Spokane	Washington
United States	Research Site	Spokane	Washington
United States	Research Site	Springfield	Missouri
United States	Research Site	Suffolk	Virginia
United States	Research Site	Sylvania	Ohio
United States	Research Site	Topeka	Kansas
United States	Research Site	Troy	Michigan
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Vero Beach	Florida
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wichita	Kansas
United States	Research Site	Wichita	Kansas
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Alizyme

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		One year	No
Secondary	Vital signs, routine clinical laboratory data, 12-lead ECG		One year	No