Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)

Last updated: December 17, 2013
Sponsor: Tioga Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Stomach Discomfort

Colic

Lactose Intolerance

Treatment

Placebo

Asimadoline

Clinical Study ID

NCT01100684
ASMP3001
  • Ages 18-79
  • All Genders

Study Summary

The purpose of this study is to determine whether asimadoline is safe and effective at treating D-IBS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signs and dates a written informed consent form.

  2. Male and female subjects aged 18-79 who are fluent in English

  3. All subjects must use protocol specified contraceptive measures

  4. The subject is or has been diagnosed with IBS with symptom onset at least 6 monthsprior to diagnosis. IBS is defined as the subject having recurrent abdominal pain ordiscomfort at least 3 days per month in the past 3 months associated with at least twoof the following symptoms: Improvement with defecation Onset associated with a change in frequency of stool Onsetassociated with a change in form (appearance) of stool

  5. The subject has been diagnosed with diarrhea-predominant IBS

  6. Within 2 years of the randomization visit, the subject has normal results from aflexible sigmoidoscopy, a colonoscopy, or a barium enema plus flexible sigmoidoscopy,according to the subject's age by a specified algorithm.

Exclusion

Exclusion Criteria:

  1. The subject exhibits evidence of a biochemical or structural abnormality of thedigestive tract.

  2. Subject has a concurrent illness or disability (excluding IBS) that may affect theinterpretation of clinical efficacy and/or safety data or otherwise contraindicatesparticipation in this clinical study (e.g., an unstable cardiovascular, renal,hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurologicalcondition).

  3. The subject has a family history of prolonged QT syndrome.

  4. The subject has been diagnosed with a major psychiatric disorder.

  5. The subject has a history of alcohol or substance abuse within the past 2 years.

  6. The subject has a history or current evidence of laxative abuse

  7. The subject has a positive stool sample for ova or parasite.

  8. The subject has used an investigational drug or participated in an investigationalstudy within 30 days of screening.

  9. The subject refuses to discontinue one (or more) prohibited medications at least 7days prior to the screening visit.

  10. The subject refuses to maintain a stable dose of one (or more) allowable concurrentmedications for at least 30 days prior to the screening visit.

  11. The subject is a pregnant woman or a woman who is breast feeding.

  12. The subject is unable or unwilling to follow directions or use the electronic diarysystem.

Study Design

Total Participants: 611
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 01, 2010
Estimated Completion Date:
June 30, 2013

Study Description

The primary objective of the study is to compare the efficacy of the two treatments with respect to improvement in IBS-related abdominal pain severity and reduction in stool frequency. During the 12-week treatment period, daily IBS-related abdominal pain severity score and daily frequency of bowel movements will be averaged over each week to determine average values for each endpoint. For each subject, weekly response to treatment will be based on the following parameters:

  • Decrease from baseline of at least 30% in the average IBS-related daily abdominal pain severity score

  • Decrease from baseline of at least 25% in the average number of daily bowel movements A subject must meet both criteria to be considered a weekly responder. The primary efficacy endpoint is based on an "overall study responder," defined as a subject having 6 or more weeks of weekly response to treatment out of the 12 weeks in the treatment period. Overall study responder will be stratified by timing of bowel preparation and endoscopy.

Connect with a study center

  • North Alabama Research Center, LLC

    Athens, Alabama 35611
    United States

    Site Not Available

  • Alliance Clinical Research

    Birmingham, Alabama 35213
    United States

    Site Not Available

  • PrimeTeam

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Alliance Clinical Research

    Gulf Shores, Alabama 36542
    United States

    Site Not Available

  • Clinical Research Consultants Inc

    Hoover, Alabama 35216
    United States

    Site Not Available

  • Medical Affliated Research Center, Inc.

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Saadat Ansari MD LLC

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Scottsboro Quick Care Clinic

    Scottsboro, Alabama 35768
    United States

    Site Not Available

  • Greater Arizona Gastroenterology Associates

    Casa Grande, Arizona 85122
    United States

    Site Not Available

  • Connect Clinical Research Center

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Novara Clinical Research

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Digestive Health Research Unit

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • ACRC/Arizona Clinical Research Center, Inc.

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Adobe Clinical Research, LLC

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Genova Clinical Research

    Tucson, Arizona 85741
    United States

    Site Not Available

  • W/C Clinical Research

    Tucson, Arizona 85741
    United States

    Site Not Available

  • Applied Research Center of Arkansas

    Little Rock, Arkansas 72212
    United States

    Site Not Available

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Arkansas Gastroenterology

    Sherwood, Arkansas 72120
    United States

    Site Not Available

  • Providence Clinical Research

    Burbank, California 91505
    United States

    Site Not Available

  • GW Research Inc,

    Chula Vista, California 91910
    United States

    Site Not Available

  • La Jolla Clinical Research, Inc

    Chula Vista, California 91911
    United States

    Site Not Available

  • Discovery Clinical Research

    Encinitas, California 92024
    United States

    Site Not Available

  • Family Medical Center

    Foothill Ranch, California 92610
    United States

    Site Not Available

  • Digestive & Liver Disease Specialist

    Garden Grove, California 92840
    United States

    Site Not Available

  • Collaborative Neuroscience Network Inc

    Long Beach, California 90808
    United States

    Site Not Available

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • California Gastroenterology Associates

    Madera, California 93637
    United States

    Site Not Available

  • Community Clinical Trials

    Orange, California 92868
    United States

    Site Not Available

  • Apex Research of Riverside

    Riverside, California 92505
    United States

    Site Not Available

  • Sutter Medical Group Gastroenterology

    Sacramento, California 95816
    United States

    Site Not Available

  • Digestive Care Associates

    San Carlos, California 94070
    United States

    Site Not Available

  • Medical Associates Research Group, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Medical Center for Clinical Research

    San Diego, California 92108
    United States

    Site Not Available

  • Westlake Medical Research

    Westlake Village, California 91361
    United States

    Site Not Available

  • Lynne Institute of the Rockies

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Arapahoe Gastroenterology

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Lynn Institute of Pueblo

    Pueblo, Colorado 81008
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology Associates

    Thornton, Colorado 80229
    United States

    Site Not Available

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Danbury Clinical Research, LLC

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • University of Connecticut Health Center/Gastroenterolory

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Litchfield County Gastroenterology and Associates

    Torrington, Connecticut 06790
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Boca Raton Clinical Research Associates

    Boca Raton, Florida 33432
    United States

    Site Not Available

  • Consultants for Clinical Research of South Florida

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Meridien Research

    Brookville, Florida 34601
    United States

    Site Not Available

  • Primus Medical Research INC

    Cape Coral, Florida 33904
    United States

    Site Not Available

  • BioPharma Research

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Riverside Clinical Research

    Edgewater, Florida 32132
    United States

    Site Not Available

  • A.G.A. Clinical Trials

    Hialeah, Florida 33012
    United States

    Site Not Available

  • Altus Research

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Center for Advanced Gastroenterology

    Maitland, Florida 32751
    United States

    Site Not Available

  • FIRC

    Miami, Florida 33166
    United States

    Site Not Available

  • Compass Research, LLC

    Orlando, Florida 32806
    United States

    Site Not Available

  • DMI Research

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Accord Clinical Research, LLC

    Port Orange, Florida 32129
    United States

    Site Not Available

  • International Clinical Research-US,LLC

    Sanford, Florida 32771
    United States

    Site Not Available

  • Meridien Research

    St. Petersburg, Florida 33709
    United States

    Site Not Available

  • Lakeview Medical Research

    Summerfield, Florida 34491
    United States

    Site Not Available

  • Venra Clinical Studies, LLC

    Wellington, Florida 33414
    United States

    Site Not Available

  • Alliance Clinical Research

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Atlanta Center for Gastroenterology

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Tri County Research

    Hartwell, Georgia 30643
    United States

    Site Not Available

  • North Georgia Clinical Research

    Woodstock, Georgia 30189
    United States

    Site Not Available

  • Northwest Gastroenterologist S.C.

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Healthcare Research Network

    Bourbonnais, Illinois 30914
    United States

    Site Not Available

  • Illinois Center for Clinical Research

    Chicago, Illinois 60622
    United States

    Site Not Available

  • Southwest Gastroenterology

    Oak Lawn, Illinois 60453
    United States

    Site Not Available

  • Rockford Gastroenterology Associates. Ltd.

    Rockford, Illinois 61107
    United States

    Site Not Available

  • Elkhart Clinic, LLC/Indiana Medical Research, LLC

    Elkhart, Indiana 46514
    United States

    Site Not Available

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Ireland Medical Group

    South Bend, Indiana 46614
    United States

    Site Not Available

  • Mercy Gastroenterology Clinic

    Clive, Iowa 50325
    United States

    Site Not Available

  • Gastrointestinal Clinic of Quad Cities

    Davenport, Iowa 52807
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Heartland Research Associates, LLC

    Newton, Kansas 67114
    United States

    Site Not Available

  • Heartland Research Associates, LLC

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Graves-Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Tri-State Gastroenterology Associates, PSC

    Crestview Hills, Kentucky 41017
    United States

    Site Not Available

  • Hometown Urgent Care and Research

    Hebron, Kentucky 41048
    United States

    Site Not Available

  • The Research Group of Lexington, LLC

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • University of Louisville Medical-Dental Complex

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Tover Health Systems Center for Clinical Research

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Investigative Clinical Research

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Meritus Center for Clinical Resarch

    Hagerstown, Maryland 21742
    United States

    Site Not Available

  • Spectrum Clinical Research Inc.

    Towson, Maryland 21204
    United States

    Site Not Available

  • Commonwealth Clinical Studies

    Brockton, Massachusetts 02302
    United States

    Site Not Available

  • NECCR Internal Medicine and Cardiology Associates LLC

    Fall River, Massachusetts 02720
    United States

    Site Not Available

  • ActivMed Practices and Research

    Haverhill, Massachusetts 01830
    United States

    Site Not Available

  • Heffron Clinic

    Adrian, Michigan 49221
    United States

    Site Not Available

  • University of Michigan Health System

    Ann Arbor, Michigan 48009
    United States

    Site Not Available

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Beyer Research

    Kalamazoo, Michigan 49009
    United States

    Site Not Available

  • Saginaw Valley Medical Research Group, LLC

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Gastrointestinal Accociates, PA

    Jackson, Mississippi 39202
    United States

    Site Not Available

  • Digestive Research Specialist

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Healthcare Research Network

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • Midwest Center for Clinical Research

    Lees Summit, Missouri 64064
    United States

    Site Not Available

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri 65265
    United States

    Site Not Available

  • St. Louis Center for Clinical Research

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Montana Health Research Institute, Inc.

    Billings, Montana 59102
    United States

    Site Not Available

  • Dr. Meera Dewan PC

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Anderson & Collins Clinical Research

    Edison, New Jersey 08817
    United States

    Site Not Available

  • South Jersey Gastroenterology. P.A.

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Atlantic Research Affiliates

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Jeffrey Danzig, MD

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Life Medi-Research

    Brooklyn, New York 11206
    United States

    Site Not Available

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York 11021
    United States

    Site Not Available

  • Long Island Gastrointestinal Research Group

    Great Neck, New York 11023
    United States

    Site Not Available

  • Winthrop University Hospital Clinical Trials Center

    Mineola, New York 11501
    United States

    Site Not Available

  • Weill Greenberg Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • Research Associates of New York

    New York,, New York 10075
    United States

    Site Not Available

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Gastrointestinal Research Associates, LLC

    Setauket, New York 11733
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794-8173
    United States

    Site Not Available

  • Asheville Gastroenterology Associates

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • The UNC Center for Functional GI and Motility Disorders

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Carolina Digestive Health Associates

    Davidson, North Carolina 28036
    United States

    Site Not Available

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • LeBauer Research Associates, P.A.

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Carolina Digestive Diseases, Carolina Research

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • PMG Research of Hickory, LLC

    Hickory, North Carolina 28602
    United States

    Site Not Available

  • Peters Medical Research

    High Point, North Carolina 27262
    United States

    Site Not Available

  • East Carolina Gastroenterology

    Jacksonville, North Carolina 28546
    United States

    Site Not Available

  • Kinston Medical Specialist, P.A.

    Kinston, North Carolina 28501
    United States

    Site Not Available

  • Wake Research Associates

    Raleigh, North Carolina 27616
    United States

    Site Not Available

  • Trial Management Associates LLC

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Lillestol Research LLC

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Akron Gastroenterology Associates

    Akron, Ohio 44302
    United States

    Site Not Available

  • Gastroenterology Research Consultants of Greater Cincinnati

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Hometown Urgent Care

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Hometown Urgent Care

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Hometown Urgent Care and Research

    Groveport, Ohio 43125
    United States

    Site Not Available

  • Hometown Urgent Care and Research

    Miamisburg, Ohio 45342
    United States

    Site Not Available

  • IRM/ Oregon Clinic

    Oregon, Ohio 43616
    United States

    Site Not Available

  • Avamar Gastroenterology

    Warren, Ohio 44484
    United States

    Site Not Available

  • Physicians Research, Inc

    Zanesville, Ohio 43701
    United States

    Site Not Available

  • Journey Clinical Research

    Duncan, Oklahoma 73533
    United States

    Site Not Available

  • Central Sooner Research

    Norman, Oklahoma 73071
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Sooner Clinical Research

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Options Health Research

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Northwest Gastroenterology Clinic, LLC

    Portland, Oregon 97210
    United States

    Site Not Available

  • Kandra Fierer Kiskin Associates, Ltd.

    Harrisburg, Pennsylvania 17112
    United States

    Site Not Available

  • PMA Medical Specialists

    Limerick, Pennsylvania 19468
    United States

    Site Not Available

  • TriValley Primary Care-Pennridge

    Perkasie, Pennsylvania 18944
    United States

    Site Not Available

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania 15206
    United States

    Site Not Available

  • Premium Office

    Sellersville, Pennsylvania 18960
    United States

    Site Not Available

  • Ilumina Clinical Associates

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Safe Harbor Clinical Research

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Southeast Medical Research

    Charleston, South Carolina 29406
    United States

    Site Not Available

  • SC Clinical Research, LLC

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Coastal Carolina Research Center in Goose Creek

    Goose Creek, South Carolina 29445
    United States

    Site Not Available

  • James T. Martin, Jr., M.D., OBGYN

    North Charleston, South Carolina 29406
    United States

    Site Not Available

  • Hillcrest Clinical Research, LLC

    Simpsonville, South Carolina 29681
    United States

    Site Not Available

  • Midwest Medical Care

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Gastroenterology Associates

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Alpha Clinical Research

    Clarksville, Tennessee 37043
    United States

    Site Not Available

  • Memphis Gastroenterology Group

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Associates in Gastroenterology

    Hermitage, Tennessee 37076
    United States

    Site Not Available

  • Gastroenterology Associates Clinical Research

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Columbia Medical Group -The First Clinic, Inc.

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Dial Research Associates, INC

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • TN Medical Research

    Spring Hill, Tennessee 37147
    United States

    Site Not Available

  • Research Across America/ Family Medicine Associates of Texas

    Carrollton, Texas 75010
    United States

    Site Not Available

  • Corsicana Medical Research, PLLC

    Corsicana, Texas 75110
    United States

    Site Not Available

  • Texas University Health Sciences Center

    El Paso, Texas 79905
    United States

    Site Not Available

  • Gastroenterology Consultants, P.A.

    Houston, Texas 77034
    United States

    Site Not Available

  • Houston S. Endoscopy and Research Center

    Houston, Texas 77079
    United States

    Site Not Available

  • Pioneer Research Solutions, Inc

    Houston, Texas 77098
    United States

    Site Not Available

  • Spring Gastroenterology Associates

    Humble, Texas 77338
    United States

    Site Not Available

  • Digestive Health Associates of Texas

    Plano, Texas 75075
    United States

    Site Not Available

  • Clinical Trials of Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Sun Research Institute

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Pioneer Research Solutions, Inc.

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Advanced Research Institute

    Clinton, Utah 84015
    United States

    Site Not Available

  • Advanced Research Institute

    Logan, Utah 84341
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Site Not Available

  • Advanced Research Institute

    Sandy, Utah 84094
    United States

    Site Not Available

  • Charlottesville Medical Reserch

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • Gastroenterology, Ltd.

    Virginia Beach, Virginia 23454
    United States

    Site Not Available

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Discovery Research

    West Bend, Wisconsin 53095
    United States

    Site Not Available

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