Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00454688
• Other study ID #: ASMP2003
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2007
• Last updated: October 17, 2011
• Start date: August 2006
• Est. completion date: December 2007

Study information

• Verified date: October 2011
• Source: Tioga Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Asimadoline
Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks
• Placebo
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Tioga Pharmaceuticals	RTI Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of IBS Pain - total months	The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.	12 weeks	No
Secondary	Relief of IBS Pain - percent of patients	Proportion of subjects with adequate relief of IBS pain or discomfort	12 weeks	No
Secondary	Relief of IBS Symptoms	Adequate relief of IBS symptoms	12 weeks	No
Secondary	Lower GI function - change from baseline	Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)	12 weeks	No
Secondary	Abdominal Pain Score - change from baseline	Change from baseline in abdominal pain score	12 weeks	No
Secondary	Abdominal Discomfort Score - change from baseline	Change from baseline in abdominal discomfort score	12 weeks	No