Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Asimadoline

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.

• Study Type: Interventional
• Enrollment (Actual): 596
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center
  • Arizona
    • Pheonix, Arizona, United States, 85016
      • Lovelace Scientific Resources
    • Phoenix, Arizona, United States, 85029
      • Redpoint Research
    • Phoenix, Arizona, United States, 85016
      • Lovelace Scientific Resources
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Scottsdale - Division of Gastroenterology
    • Tucson, Arizona, United States, 85741
      • Genova Clinical Research
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Gastroenterology
  • California
    • Elk Grove, California, United States, 95758
      • Sutter Institute for Medical Research
    • Garden Grove, California, United States, 92840
      • Digestive & Liver Disease Specialists
    • Irvine, California, United States, 92618
      • Irvine Center for Clinical Research Inc.
    • Orange, California, United States, 92868
      • Community Clinical Trials
    • Sacramento, California, United States, 95816
      • Sutter Institute for Medical Research
    • Sacramento, California, United States, 95831
      • Nothern California Research
    • Westlake Village, California, United States, 91361
      • Westlake Medical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Lynn Institute Of The Rockies
    • Longmont, Colorado, United States, 80501
      • Longmont Medical Research Network
    • Wheat Ridge, Colorado, United States, 80033
      • Western States Clinical Research Inc
  • Connecticut
    • Stratford, Connecticut, United States, 06615
      • Clinical Research Consultants, LLC
    • Waterbury, Connecticut, United States, 06708
      • Phoenix Internal Medicine Associates, Llc
  • Florida
    • Brooksville, Florida, United States, 34613
      • Meridian Research
    • Gainesville, Florida, United States, 32607
      • Florida Medical Research Institute
    • Hialeah, Florida, United States, 33010
      • Research Consultants Group
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research
    • Orlando, Florida, United States, 32833
      • Universal Clinical Research & Technology
    • Ormond Beach, Florida, United States, 32174
      • Penninsula Research, Inc
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research - St. Petersburg
    • Sarasota, Florida, United States, 34233
      • Lovelace Scientific Resources
    • St Petersburg, Florida, United States, 33709
      • Meridien Research
    • Tampa, Florida, United States, 33606
      • Meridien Research
  • Georgia
    • Marietta, Georgia, United States, 30067
      • Michael S. Levine, MD
    • Sandy Springs, Georgia, United States, 30318
      • Mount Vernon Clinical Research
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Gastroenterologists S.C.
    • Chicago, Illinois, United States, 60622
      • Illinois Center for Clinical Research
    • Oak Forest, Illinois, United States, 60452
      • University Digestive Health Center
    • Riverside, Illinois, United States, 60546
      • BHS Digestive Disease Associates
    • Rockford, Illinois, United States, 61107
      • Rockford Gastroenterology Associates LTD
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indianapolis Gastroenterology Research Foundation
  • Iowa
    • Clive, Iowa, United States, 50325
      • Heartland Medical Research, Inc
  • Kansas
    • Wichita, Kansas, United States, 67207
      • Heartland Research Associates, LLC
    • Wichita, Kansas, United States, 67203
      • Professional Research Network of Kansas
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville GI Research
    • Madisonville, Kentucky, United States, 42431
      • Commonwealth Biomedical Research, LLC
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Digestive Health Center of Louisianna
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Digestive Disorders Associate
    • Baltimore, Maryland, United States, 21208
      • Woodholme Gastroenterology Associates, PA
    • Baltimore, Maryland, United States, 21229
      • Digestive Diseases Associates, PA
    • Chevy Chase, Maryland, United States, 20815
      • Chevy Chase Clinical Research MGG
    • Reisterstown, Maryland, United States, 21136
      • Clinical Associates Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • Ridgeview Research
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Gastrointestinal Associates, PA
    • Olive Branch, Mississippi, United States, 38654
      • Olive Branch Family Medical Center
  • Missouri
    • St. Louis, Missouri, United States, 63128
      • St. Louis Center for Clinical Research
  • Montana
    • Billings, Montana, United States, 59102
      • Montana Health Research Institute
  • Nebraska
    • Lincoln, Nebraska, United States, 68503
      • Gastroenterology Specialties, PC
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
    • Omaha, Nebraska, United States, 68144
      • Dr. Meera Dewan, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clinical Research & Osteoporosis Center
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates
    • New York, New York, United States, 10021
      • Cornell Weill Medical College
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates, PA
    • Cary, North Carolina, United States, 27511
      • Cary Medical Research Associates
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill
    • Charlotte, North Carolina, United States, 28209
      • Metrolina Medical Research
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroenterology and Hepatology
    • Fayetteville, North Carolina, United States, 28304
      • Cumberland Research Associates
    • Greensboro, North Carolina, United States, 27403
      • LeBauer Research Associates, PA
    • Hickory, North Carolina, United States, 28601
      • Unifour Medical Research Associates
    • Raleigh, North Carolina, United States, 27609
      • Triangle Medical Research Associates
    • Salisbury, North Carolina, United States, 28144
      • Crescent Medical Research
    • Wilmington, North Carolina, United States, 28401
      • Hanover Medical Specialists, PA
    • Wilmington, North Carolina, United States, 28412
      • New Hannover Medical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Medical Research Associates
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron Gastroenterology Assoc, Inc.
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
    • Cincinnati, Ohio, United States, 45220
      • Digestive Health Network
    • Columbus, Ohio, United States, 43212
      • Radiant Research
    • Kettering, Ohio, United States, 45429
      • Wells Institute for Health Awareness
    • Mogadore, Ohio, United States, 44260
      • Radiant Research - Akron
  • Oklahoma
    • Norman, Oklahoma, United States, 73701
      • Lion Research
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Foundation for Digestive Research
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC
    • Tulsa, Oklahoma, United States, 74136
      • Castlerock Clinical Research Consultants, Llc
  • Oregon
    • Portland, Oregon, United States, 97210
      • NW Gastroenterology Clinic
    • Portland, Oregon, United States, 97225
      • West Hills Gastroenterology Associates, PC
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Center for Digestive Health
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Clinical Research
  • Rhode Island
    • East Providence, Rhode Island, United States, 02917
      • Safe Harbor Clinical Research
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
    • Mt. Pleasant, South Carolina, United States, 29464
      • Palmetto Medical Research
    • Simpsonville, South Carolina, United States, 29681
      • Hillcrest Clinical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • ClinSearch
    • Clarksville, Tennessee, United States, 37043
      • Alpha Clinical Research,LLC
    • Germantown, Tennessee, United States, 38138
      • Memphis Gastroenterology Group
    • Kingsport, Tennessee, United States, 37660
      • Gastroenterology Associates
    • Nashville, Tennessee, United States, 37205
      • Dial Research Associates, Inc
  • Texas
    • Austin, Texas, United States, 78752
      • Covance CRU-Austin
    • Conroe, Texas, United States, 77304
      • Sadler Clinic
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center
    • Houston, Texas, United States, 77074
      • Clinical Trials Network
    • Houston, Texas, United States, 77004
      • Discovery Alliance
    • Houston, Texas, United States, 77036
      • Nationsmed Clinical Research
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center
    • San Antonio, Texas, United States, 78205
      • Sun Research Institute
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research Inc., Foothills Family Clinic
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Christiansburg, Virginia, United States, 24073
      • New River Valley Research Institute
    • Richmond, Virginia, United States, 23294
      • National Clinical Research inc
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
EXPERIMENTAL: Asimadoline 0.15 mg	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; Other Names: EMD 61753; EMR 63320
EXPERIMENTAL: Asimadoline 0.5 mg	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; Other Names: EMD 61753; EMR 63320
EXPERIMENTAL: Asimadoline 1.0 mg	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; Other Names: EMD 61753; EMR 63320

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relief of IBS Pain - percent of patients	Proportion of subjects with adequate relief of IBS pain or discomfort	12 weeks
Relief of IBS Symptoms	Adequate relief of IBS symptoms	12 weeks
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
Abdominal Pain Score - change from baseline	Change from baseline in abdominal pain score	12 weeks
Abdominal Discomfort Score - change from baseline	Change from baseline in abdominal discomfort score	12 weeks

Collaborators and Investigators

• Sponsor: Tioga Pharmaceuticals
• Collaborators: RTI Health Solutions
• Investigators: Study Chair: Allen Mangel, MD, PhD, Tioga Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: March 29, 2007
• First Submitted That Met QC Criteria: March 29, 2007
• First Posted (ESTIMATE): April 2, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2011
• Last Update Submitted That Met QC Criteria: October 17, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Asimadoline
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: ASMP2003