Clinical trial NCT00607971: Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Constipation-Predominant Irritable Bowel Syndrome
Keywords: Constipation predominant irritable bowel syndrome
Lead sponsor: Alizyme
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 939
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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).

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Subjects who are pregnant or breastfeeding

Primary outcomes:
measure: Adverse events
timeFrame: One year
Secondary outcomes:
measure: Vital signs, routine clinical laboratory data, 12-lead ECG
timeFrame: One year
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Sierra Vista
country: United States
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state: Arizona
city: Little Rock
country: United States
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state: Arkansas
city: North Little Rock
country: United States
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state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Beverley Hills
country: United States
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state: California
city: Burbank
country: United States
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state: California
city: Carmichael
country: United States
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state: California
city: Cerritos
country: United States
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state: California
city: Chula Vista
country: United States
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state: California
city: Cypress
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state: California
city: Laguna Hills
country: United States
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state: California
city: Los Angeles
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state: California
city: Orange
country: United States
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city: Orange
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city: San Carlos
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city: San Diego
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city: San Diego
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city: Colorado Springs
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city: Lakewood
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city: Littleton
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city: Bristol
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state: Connecticut
city: Boynton Beach
country: United States
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city: Coral Gables
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city: Newnan
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city: Rockford
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city: Indianapolis
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city: Des Moines
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city: Overland Park
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city: Annapolis
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city: Hagerstown
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city: Laurel
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city: Pasadena
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city: Severna Park
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city: Boston
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city: Boston
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city: Chesterfield
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city: Lansing
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city: Troy
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city: Cedar Knolls
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city: Passaic
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city: Sicklerville
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city: Great Neck
country: United States
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city: Great Neck
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city: Johnson City
country: United States
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city: Kingston
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city: Mineola
country: United States
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city: New York
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state: New York
city: Burlington
country: United States
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state: North Carolina
city: Charlotte
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state: North Carolina
city: Elkin
country: United States
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city: Fayetteville
country: United States
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city: Greensboro
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city: Greensboro
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city: New Bern
country: United States
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city: Pinehurst
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city: Raleigh
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city: Wilmington
country: United States
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city: Wilmington
country: United States
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city: Winston-Salem
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city: Bismark
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city: Fargo
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city: Cincinnati
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city: Columbus
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city: Mogadore
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city: Sylvania
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city: Zanesville
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city: Norman
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city: Oklahoma City
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state: Oklahoma
city: Downington
country: United States
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state: Pennsylvania
city: Lancaster
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city: Pittsburgh
country: United States
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city: Greer
country: United States
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state: South Carolina
city: Simpsonville
country: United States
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state: South Carolina
city: Chattanooga
country: United States
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state: Tennessee
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Germantown
country: United States
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state: Tennessee
city: Jackson
country: United States
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state: Tennessee
city: Kingsport
country: United States
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state: Tennessee
city: Knoxville
country: United States
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state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Nashville
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: Corsicana
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: FT. Worth
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
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state: Texas
city: Murray
country: United States
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state: Utah
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Suffolk
country: United States
facility: Research Site
state: Virginia
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Beth Israel Deaconess Medical Center, Boston
name: Anthony Lembo, MD
role: PRINCIPAL_INVESTIGATOR
References: