A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Last updated: November 13, 2020
Sponsor: Ironwood Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Colic

Lactose Intolerance

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT03573908
MCP-103-312
  • Ages > 18
  • All Genders

Study Summary

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient has no clinically significant findings on a physical examination and clinicallaboratory tests
  • Female patients of childbearing potential must agree to use one of the followingmethods of birth control:
  1. Hormonal contraception
  2. Double-barrier birth control
  3. Maintenance of a monogamous relationship with a male partner who has beensurgically sterilized by vasectomy
  • Patient meets protocol criteria for diagnosis of IBS-C
  • Patient demonstrates continued IBS-C symptoms through Pretreatment Period
  • Patient maintains a minimum level of compliance with daily diary

Exclusion

Exclusion Criteria:

  • Patient has history of loose or watery stools
  • Patient has symptoms of or been diagnosed with a medical condition that may contributeto abdominal pain
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a diseaseor condition that can affect GI motility
  • Patient has any protocol-excluded or clinically significant medical or surgicalhistory that could confound the study assessments

Study Design

Total Participants: 614
Study Start date:
June 20, 2018
Estimated Completion Date:
April 10, 2019

Study Description

This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.

Connect with a study center

  • Clinical Research Associates

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Elite Clinical Studies

    Phoenix, Arizona 85018
    United States

    Site Not Available

  • Adobe Clinical Research, LLC

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Arkansas Gastroenterology

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • GW Research, Inc.

    Chula Vista, California 91910
    United States

    Site Not Available

  • Kindred Medical Institute for Clinical Trials, LLC

    Corona, California 92879
    United States

    Site Not Available

  • Diagnamics, Inc.

    Encinitas, California 92024
    United States

    Site Not Available

  • MD Studies, Inc.

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Paragon Rx Clinical, Inc. - Garden Grove

    Garden Grove, California 92840
    United States

    Site Not Available

  • Grossmont Center For Clinical Research

    La Mesa, California 91942
    United States

    Site Not Available

  • Facey Medical Foundation

    Mission Hills, California 91345
    United States

    Site Not Available

  • Providence Clinical Research

    North Hollywood, California 91606
    United States

    Site Not Available

  • Precision Research Institute

    San Diego, California 92114
    United States

    Site Not Available

  • Paragon Rx Clinical, Inc.- Santa Ana

    Santa Ana, California 92703
    United States

    Site Not Available

  • Millennium Clinical Trials

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • St. Joseph Heritage Healthcare

    Yorba Linda, California 92886
    United States

    Site Not Available

  • Connecticut Clinical Research Institute

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • Chase Medical Research, LLC

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Clinical Research of South Florida

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Avail Clinical Research, LLC

    DeLand, Florida 32720
    United States

    Site Not Available

  • Palmetto Research, LLC

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Nature Coast Clinical Research, LLC

    Inverness, Florida 34452
    United States

    Site Not Available

  • The Chappel Group Research

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Precision Clinical Research

    Lauderdale Lakes, Florida 33319
    United States

    Site Not Available

  • Jesscan Medical Research

    Miami, Florida 33134
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33175
    United States

    Site Not Available

  • Well Pharma Medical Research Corporation

    Miami, Florida 33143
    United States

    Site Not Available

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida 33014
    United States

    Site Not Available

  • Ocean Blue Medical Research Center, Inc.

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Ormond Medical Arts Pharmaceutical Research Center

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • Precision Clinical Research

    Sunrise, Florida 33351
    United States

    Site Not Available

  • Meridien Research - Tampa

    Tampa, Florida 33634
    United States

    Site Not Available

  • Palm Beach Research Center

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Research Institute of Central Florida, LLC

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Clinical Trials Management, LLC

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Delta Research Partners, LLC

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71105
    United States

    Site Not Available

  • Alan A. Rosen, MD, PA

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • Meritus Center For Clinical Research

    Hagerstown, Maryland 21742
    United States

    Site Not Available

  • Boston Clinical Trials, Inc.

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • MedVadis Research Corporation

    Watertown, Massachusetts 02472
    United States

    Site Not Available

  • Gastroenterology Associates of West Michigan

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Gastrointestinal Associates PA

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • St. Louis Center For Clinical Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana 59718
    United States

    Site Not Available

  • Clinical Research of South Nevada

    Las Vegas, Nevada 89121
    United States

    Site Not Available

  • Healthwise Medical Associates

    Brooklyn, New York 11206
    United States

    Site Not Available

  • Long Island Gastrointestinal Research Group, LLP

    Great Neck, New York 11023
    United States

    Site Not Available

  • Carolina Digestive Health Associates

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Carolina Digestive Health Associates

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Cumberland Research Associates

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Peters Medical Research, LLC

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Wake Research Associates, LLC

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • PMG Research of Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Clinical Trials of America - North Carolina, LLC

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Hightop Medical Research Center

    Cincinnati, Ohio 45224
    United States

    Site Not Available

  • New Horizons Clinical Research

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Remington Davis, Inc.

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Dayton Gastroenterology, Inc.

    Dayton, Ohio 45415
    United States

    Site Not Available

  • Hometown Urgent Care and Research

    Dayton, Ohio 45424
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Site Not Available

  • IPS Research Company

    Oklahoma City, Oklahoma 73106
    United States

    Site Not Available

  • Partners In Clinical Research

    Cumberland, Rhode Island 02864
    United States

    Site Not Available

  • Mountain View Clinical Research, Inc.

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Meridian Clinical Research

    Dakota Dunes, South Dakota 57049
    United States

    Site Not Available

  • ClinSearch, LLC

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • New Phase Research & Development

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • MW Clinical Research Center

    Beaumont, Texas 77701
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Site Not Available

  • Southwest Clinical Trials

    Houston, Texas 77081
    United States

    Site Not Available

  • Diagnostics Research Group

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Quality Research, Inc.

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Stone Oak, LLC dba Discovery Clinical Trials

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Advanced Research Institute

    Ogden, Utah 84405
    United States

    Site Not Available

  • New River Valley Research Institute

    Christiansburg, Virginia 24073
    United States

    Site Not Available

  • Blue Ridge Medical Research

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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