Clinical trial NCT00454688: Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
Official title: A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Asimadoline
Lead sponsor: Tioga Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions
First posted: 2007-04-02
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.

Detailed description: A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.

Eligibility criteria: Inclusion Criteria:

* Males and females aged 18-79
* Must sign an ICF
* Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
* Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
* Must demonstrate a willingness to comply with daily telephone diary entry

Exclusion Criteria:

* Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
* Pregnant or breastfeeding females
* Refusal to discontinue prohibited concomitant medications
* Use of an investigational drug or participation in an investigational study within 30 days of screening
* Inability or unwillingness to use the touch-tone telephone data entry system

Primary outcomes:
measure: Relief of IBS Pain - total months
timeFrame: 12 weeks
Secondary outcomes:
measure: Relief of IBS Pain - percent of patients
timeFrame: 12 weeks
measure: Relief of IBS Symptoms
timeFrame: 12 weeks
measure: Lower GI function - change from baseline
timeFrame: 12 weeks
measure: Abdominal Pain Score - change from baseline
timeFrame: 12 weeks
measure: Abdominal Discomfort Score - change from baseline
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Pheonix
country: United States
facility: Lovelace Scientific Resources
state: Arizona
city: Phoenix
country: United States
facility: Lovelace Scientific Resources
state: Arizona
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale - Division of Gastroenterology
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Elk Grove
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Garden Grove
country: United States
facility: Digestive & Liver Disease Specialists
state: California
city: Irvine
country: United States
facility: Irvine Center for Clinical Research Inc.
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: Sacramento
country: United States
facility: Nothern California Research
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of the Rockies
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research Inc
state: Colorado
city: Stratford
country: United States
facility: Clinical Research Consultants, LLC
state: Connecticut
city: Waterbury
country: United States
facility: Phoenix Internal Medicine Associates, LLC
state: Connecticut
city: Brooksville
country: United States
facility: Meridian Research
state: Florida
city: Gainesville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Hialeah
country: United States
facility: Research Consultants Group
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Orlando
country: United States
facility: Universal Clinical Research & Technology
state: Florida
city: Ormond Beach
country: United States
facility: Penninsula Research, Inc
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research - St. Petersburg
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: St Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Marietta
country: United States
facility: Michael S. Levine, MD
state: Georgia
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Gastroenterologists S.C.
state: Illinois
city: Chicago
country: United States
facility: Illinois Center for Clinical Research
state: Illinois
city: Oak Forest
country: United States
facility: University Digestive Health Center
state: Illinois
city: Riverside
country: United States
facility: BHS Digestive Disease Associates
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates Ltd
state: Illinois
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Clive
country: United States
facility: Heartland Medical Research, Inc
state: Iowa
city: Wichita
country: United States
facility: Professional Research Network of Kansas
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Louisville
country: United States
facility: University of Louisville GI Research
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Digestive Health Center of Louisianna
state: Louisiana
city: Annapolis
country: United States
facility: Digestive Disorders Associate
state: Maryland
city: Baltimore
country: United States
facility: Woodholme Gastroenterology Associates, PA
state: Maryland
city: Baltimore
country: United States
facility: Digestive Diseases Associates, PA
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research MGG
state: Maryland
city: Reisterstown
country: United States
facility: Clinical Associates Research
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates
state: Massachusetts
city: Chaska
country: United States
facility: Ridgeview Research
state: Minnesota
city: Jackson
country: United States
facility: Gastrointestinal Associates, PA
state: Mississippi
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: St. Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Billings
country: United States
facility: Montana Health Research Institute
state: Montana
city: Lincoln
country: United States
facility: Gastroenterology Specialties, PC
state: Nebraska
city: Omaha
country: United States
facility: Dr. Meera Dewan, PC
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center
state: New Mexico
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: Cornell Weill Medical College
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Cary
country: United States
facility: Cary Medical Research Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer research Associates, PA
state: North Carolina
city: Hickory
country: United States
facility: Unifour Medical Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Triangle Medical Research Associates
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists, PA
state: North Carolina
city: Wilmington
country: United States
facility: New Hannover Medical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Akron
country: United States
facility: Akron Gastroenterology Assoc, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Digestive Health Network
state: Ohio
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Kettering
country: United States
facility: Wells Institute for Health Awareness
state: Ohio
city: Mogadore
country: United States
facility: Radiant Research - Akron
state: Ohio
city: Norman
country: United States
facility: Lion Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Castlerock Clinical Research Consultants, LLC
state: Oklahoma
city: Portland
country: United States
facility: NW Gastroenterology Clinic
state: Oregon
city: Portland
country: United States
facility: West Hills Gastroenterology Associates, PC
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Center for Digestive Health
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinical Research
state: Pennsylvania
city: East Providence
country: United States
facility: Safe Harbor Clinical Research
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Clarksville
country: United States
facility: Alpha Clinical Research,LLC
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates
state: Tennessee
city: Nashville
country: United States
facility: Dial Research Associates, Inc
state: Tennessee
city: Austin
country: United States
facility: Covance CRU-Austin
state: Texas
city: Conroe
country: United States
facility: Sadler Clinic
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: Discovery Alliance
state: Texas
city: Houston
country: United States
facility: NationsMed Clinical Research
state: Texas
city: Houston
country: United States
facility: Clinical Trials Network
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc., Foothills Family Clinic
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research Inc
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: Tioga Pharmaceuticals
name: Allen Mangel, MD, PhD
role: STUDY_CHAIR
References: