Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

NCT00454688 | Completed Phase 2

• 1 other identifier: ASMP2003
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 112

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.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome; Asimadoline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Relief of IBS Pain - percent of patients

  12 weeks

• Relief of IBS Symptoms

  12 weeks

• Lower GI function - change from baseline

  12 weeks

• Abdominal Pain Score - change from baseline

  12 weeks

• Abdominal Discomfort Score - change from baseline

  12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Asimadoline 0.15 mg

EXPERIMENTAL

Drug: Asimadoline

Asimadoline 0.5 mg

EXPERIMENTAL

Drug: Asimadoline

Asimadoline 1.0 mg

EXPERIMENTAL

Drug: Asimadoline

Interventions

Asimadoline DRUG

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

Also known as: EMD 61753, EMR 63320

Asimadoline 0.15 mg; Asimadoline 0.5 mg; Asimadoline 1.0 mg

Placebo DRUG

Placebo was provided in coated tablets identical in appearance to asimadoline tablets.

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tioga Pharmaceuticals: lead
• RTI Health Solutions: collaborator

Study Sites (112)

Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States

Location

Lovelace Scientific Resources

Pheonix, Arizona, 85016, United States

Location

Lovelace Scientific Resources

Phoenix, Arizona, 85016, United States

Location

Redpoint Research

Phoenix, Arizona, 85029, United States

Location

Mayo Clinic Scottsdale - Division of Gastroenterology

Scottsdale, Arizona, 85259, United States

Location

Genova Clinical Research

Tucson, Arizona, 85741, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Sutter Institute for Medical Research

Elk Grove, California, 95758, United States

Location

Digestive & Liver Disease Specialists

Garden Grove, California, 92840, United States

Location

Irvine Center for Clinical Research Inc.

Irvine, California, 92618, United States

Location

Community Clinical Trials

Orange, California, 92868, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Nothern California Research

Sacramento, California, 95831, United States

Location

Westlake Medical Research

Westlake Village, California, 91361, United States

Location

Lynn Institute of the Rockies

Colorado Springs, Colorado, 80909, United States

Location

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

Western States Clinical Research Inc

Wheat Ridge, Colorado, 80033, United States

Location

Clinical Research Consultants, LLC

Stratford, Connecticut, 06615, United States

Location

Phoenix Internal Medicine Associates, LLC

Waterbury, Connecticut, 06708, United States

Location

Meridian Research

Brooksville, Florida, 34613, United States

Location

Florida Medical Research Institute

Gainesville, Florida, 32607, United States

Location

Research Consultants Group

Hialeah, Florida, 33010, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

Universal Clinical Research & Technology

Orlando, Florida, 32833, United States

Location

Penninsula Research, Inc

Ormond Beach, Florida, 32174, United States

Location

Radiant Research - St. Petersburg

Pinellas Park, Florida, 33781, United States

Location

Lovelace Scientific Resources

Sarasota, Florida, 34233, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Meridien Research

Tampa, Florida, 33606, United States

Location

Michael S. Levine, MD

Marietta, Georgia, 30067, United States

Location

Mount Vernon Clinical Research

Sandy Springs, Georgia, 30318, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Northwest Gastroenterologists S.C.

Arlington Heights, Illinois, 60005, United States

Location

Illinois Center for Clinical Research

Chicago, Illinois, 60622, United States

Location

University Digestive Health Center

Oak Forest, Illinois, 60452, United States

Location

BHS Digestive Disease Associates

Riverside, Illinois, 60546, United States

Location

Rockford Gastroenterology Associates Ltd

Rockford, Illinois, 61107, United States

Location

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, 46237, United States

Location

Heartland Medical Research, Inc

Clive, Iowa, 50325, United States

Location

Professional Research Network of Kansas

Wichita, Kansas, 67203, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

University of Louisville GI Research

Louisville, Kentucky, 40202, United States

Location

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, 42431, United States

Location

Digestive Health Center of Louisianna

Baton Rouge, Louisiana, 70809, United States

Location

Digestive Disorders Associate

Annapolis, Maryland, 21401, United States

Location

Woodholme Gastroenterology Associates, PA

Baltimore, Maryland, 21208, United States

Location

Digestive Diseases Associates, PA

Baltimore, Maryland, 21229, United States

Location

Chevy Chase Clinical Research MGG

Chevy Chase, Maryland, 20815, United States

Location

Clinical Associates Research

Reisterstown, Maryland, 21136, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Northeast Medical Research Associates

North Dartmouth, Massachusetts, 02747, United States

Location

Ridgeview Research

Chaska, Minnesota, 55318, United States

Location

Gastrointestinal Associates, PA

Jackson, Mississippi, 39202, United States

Location

Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

St. Louis Center for Clinical Research

St Louis, Missouri, 63128, United States

Location

Montana Health Research Institute

Billings, Montana, 59102, United States

Location

Gastroenterology Specialties, PC

Lincoln, Nebraska, 68503, United States

Location

Dr. Meera Dewan, PC

Omaha, Nebraska, 68144, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

New Mexico Clinical Research & Osteoporosis Center

Albuquerque, New Mexico, 87106, United States

Location

Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

Cornell Weill Medical College

New York, New York, 10021, United States

Location

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, 28801, United States

Location

Cary Medical Research Associates

Cary, North Carolina, 27511, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Charlotte Gastroenterology and Hepatology

Charlotte, North Carolina, 28207, United States

Location

Metrolina Medical Research

Charlotte, North Carolina, 28209, United States

Location

Cumberland Research Associates

Fayetteville, North Carolina, 28304, United States

Location

LeBauer research Associates, PA

Greensboro, North Carolina, 27403, United States

Location

Unifour Medical Research Associates

Hickory, North Carolina, 28601, United States

Location

Triangle Medical Research Associates

Raleigh, North Carolina, 27609, United States

Location

Crescent Medical Research

Salisbury, North Carolina, 28144, United States

Location

Hanover Medical Specialists, PA

Wilmington, North Carolina, 28401, United States

Location

New Hannover Medical Research

Wilmington, North Carolina, 28412, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Akron Gastroenterology Assoc, Inc.

Akron, Ohio, 44302, United States

Location

Digestive Health Network

Cincinnati, Ohio, 45220, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

Radiant Research

Columbus, Ohio, 43212, United States

Location

Wells Institute for Health Awareness

Kettering, Ohio, 45429, United States

Location

Radiant Research - Akron

Mogadore, Ohio, 44260, United States

Location

Lion Research

Norman, Oklahoma, 73701, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Castlerock Clinical Research Consultants, LLC

Tulsa, Oklahoma, 74136, United States

Location

NW Gastroenterology Clinic

Portland, Oregon, 97210, United States

Location

West Hills Gastroenterology Associates, PC

Portland, Oregon, 97225, United States

Location

Allegheny Center for Digestive Health

Pittsburgh, Pennsylvania, 15212, United States

Location

Guthrie Clinical Research

Sayre, Pennsylvania, 18840, United States

Location

Safe Harbor Clinical Research

East Providence, Rhode Island, 02917, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Palmetto Medical Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Hillcrest Clinical Research

Simpsonville, South Carolina, 29681, United States

Location

ClinSearch

Chattanooga, Tennessee, 37404, United States

Location

Alpha Clinical Research,LLC

Clarksville, Tennessee, 37043, United States

Location

Memphis Gastroenterology Group

Germantown, Tennessee, 38138, United States

Location

Gastroenterology Associates

Kingsport, Tennessee, 37660, United States

Location

Dial Research Associates, Inc

Nashville, Tennessee, 37205, United States

Location

Covance CRU-Austin

Austin, Texas, 78752, United States

Location

Sadler Clinic

Conroe, Texas, 77304, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Discovery Alliance

Houston, Texas, 77004, United States

Location

NationsMed Clinical Research

Houston, Texas, 77036, United States

Location

Clinical Trials Network

Houston, Texas, 77074, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Sun Research Institute

San Antonio, Texas, 78205, United States

Location

Advanced Research Institute

Ogden, Utah, 84405, United States

Location

J. Lewis Research Inc., Foothills Family Clinic

Salt Lake City, Utah, 84109, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

New River Valley Research Institute

Christiansburg, Virginia, 24073, United States

Location

National Clinical Research Inc

Richmond, Virginia, 23294, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

asimadoline

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Allen Mangel, MD, PhD

  Tioga Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: April 2, 2007
• Study Start: August 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 18, 2011

Record last verified: 2011-10

Locations

US (112)