An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

January 24, 2019 updated by: Forest Laboratories

An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1559

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph Healthcare
      • Newmarket, Ontario, Canada, L3Y 8E4
        • MedPhase Canada
      • Ottawa, Ontario, Canada, K2C 3R2
        • Meadowlands Family Health Center
      • Sarnia, Ontario, Canada, N7T 4X3
        • London Road Diagnostic Clinic and Medical Center
      • Sudbury, Ontario, Canada, P3E 1H5
        • Medicor Research, Inc.
      • Toronto, Ontario, Canada, M4S 1Y2
        • PrimeHealth Clinical Research
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates, Inc.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
      • Birmingham, Alabama, United States, 35205
        • Innovative Clinical Trials
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Radiant Research, Inc.
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Center
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Centers
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies, LLC
      • Phoenix, Arizona, United States, 85012
        • Carl T Hayden VA Medical Center GI Section-CS-111G
      • Scottsdale, Arizona, United States, 85251
        • Radiant Research, Inc.
      • Tucson, Arizona, United States, 85712
        • Adobe Clinical Research, LLC
      • Tucson, Arizona, United States, 85704
        • Genova Clinical Research, Inc.
    • California
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Encinitas, California, United States, 92024
        • Encompass Clinical Research North Coast
      • Foothill Ranch, California, United States, 92610
        • Family Medical Center
      • Los Angeles, California, United States, 90036
        • Axis Clinical Trials
      • Mission Hills, California, United States, 91345
        • Facey Medical Foundation
      • Orange, California, United States, 92869
        • Advanced Clinical Research Institute
      • Westlake Village, California, United States, 91361
        • Westlake Medical Research
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Boulder Medical Center, P.C.
      • Colorado Springs, Colorado, United States, 80907
        • Lynn Institute of the Rockies
      • Denver, Colorado, United States, 80205
        • Colorado Gastroenterology, Prof LLC
      • Longmont, Colorado, United States, 80501
        • Longmont Medical Research Network
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Clinical Trials Management of Boca Raton, Inc.
      • Bradenton, Florida, United States, 34208
        • Meridien Research
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Fort Myers, Florida, United States, 33916
        • Clinical Physiology Associates Clinical Study Center
      • Jupiter, Florida, United States, 33458
        • Jupiter Research, Inc.
      • Kissimmee, Florida, United States, 34741
        • FPA Clinical Research
      • Miami, Florida, United States, 33126
        • Pharmax Research Clinic
      • New Smyrna Beach, Florida, United States, 32168
        • United Medical Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Panama City, Florida, United States, 32405
        • Emerald Coast Research Associates
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc.
      • Saint Petersburg, Florida, United States, 33709
        • Meridien Research
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
      • Tampa, Florida, United States, 33606
        • Meridien Research
      • Trinity, Florida, United States, 34655
        • Advanced Research Institute
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A. Clinical Research Division
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Radiant Research, Inc.
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
      • Marietta, Georgia, United States, 30067
        • Atlanta Gastroenterology Associates, LLC
      • Stockbridge, Georgia, United States, 30281
        • Clinical Research Atlanta
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rosemark WomenCare Specialist
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Rockford Gastroenterology Associates, Ltd.
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Heartland Research Associates, LLC
      • Newton, Kansas, United States, 67114
        • Heartland Research Associates, LLC
      • Wichita, Kansas, United States, 67205
        • Heartland Research Associates, LLC
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates
      • Madisonville, Kentucky, United States, 42431
        • Trover Health System
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Medical Development Centers, LLC
      • Shreveport, Louisiana, United States, 71101
        • Clinical Trials of America, Inc.
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
      • Hagerstown, Maryland, United States, 21742
        • Meritus Center for Clinical Research
      • Towson, Maryland, United States, 21286
        • Charm City Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Boston Clinical Trials
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Kalamazoo Gastroenterology Hepatology
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Ridgeview Research Two Twelve Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • New Jersey
      • Vineland, New Jersey, United States, 08360
        • The Gastroenterology Group of S.J.
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Clinical Research and Osteoporosis Center
    • New York
      • Brooklyn, New York, United States, 11214
        • Lifeline Research Institute
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group
      • Setauket, New York, United States, 11733
        • Gastrointestinal Research Associates, LLC
    • North Carolina
      • Boone, North Carolina, United States, 28607
        • MediSpect, LLC
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Greensboro, North Carolina, United States, 27403
        • LeBauer Research Associates, P.A.
      • Hickory, North Carolina, United States, 28601
        • Clinical Trials of America, Inc
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Wilmington, North Carolina, United States, 28401
        • Hanover Medical Specialists, PA
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research, Inc.
      • Columbus, Ohio, United States, 43215
        • Remington Davis
      • Dayton, Ohio, United States, 45432
        • Hometown Urgent Care and Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Research
      • Tulsa, Oklahoma, United States, 74135
        • Gastroenterology United of Tulsa
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Clinical Trials Research Services, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Upstate Pharmaceutical Research
      • Greer, South Carolina, United States, 29651
        • Radiant Research
      • Greer, South Carolina, United States, 29651
        • Mountain View Clinical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Professional Quality Research, Inc.
      • Dallas, Texas, United States, 75234
        • Research Across America RHD Professional Plaza IV
      • Houston, Texas, United States, 77090
        • Houston Medical Research Associates
      • Houston, Texas, United States, 77090
        • Houston Digestive Diseases Clinic
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research, Inc.
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Fatigue Consultation Clinic
      • Salt Lake City, Utah, United States, 84132
        • Department of Gastroenterology University of Utah Hospital
      • Salt Lake City, Utah, United States, 84148
        • Department of Veterans Affairs Research Department
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
      • Christiansburg, Virginia, United States, 24073
        • New River Valley Research Institute
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Associates of Tidewater
      • Norfolk, Virginia, United States, 23502
        • National Clinical Research - Norfolk, Inc.
      • Richmond, Virginia, United States, 23294
        • National Clinical Research-Richmond, Inc.
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Gastroenterology Associates
      • Lakewood, Washington, United States, 98499
        • Radiant Research, Inc.
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Medical Center Clinical Research Dept.
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Advanced Healthcare, Inc. Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have

    • entered study LIN-MD 01[NCT00765882] or LIN-MD-31 [NCT00948818] and at minimum completed the pre-treatment period or
    • completed one of the following studies: MCP-103-004 [NCT00306748], MCP-103-005 [NCT00258193], MCP-103-201 [NCT00402337], MCP-103-202 [NCT00460811]
  • Sexually active patients of childbearing potential agree to use birth control
  • Females of childbearing potential must have a negative urine pregnancy test prior to dosing
  • Lactating females must agree not to breastfeed
  • Patient must meet protocol criteria for CC or IBS-C

Exclusion Criteria:

  • Patient must not use protocol-defined prohibited medicine
  • Patient is planning to receive an investigational drug at any time during the study
  • Patient has an unresolved AE or a clinically significant finding on a physical examination, 12-lead ECG, or clinical laboratory test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Linaclotide
Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
Drug: Linaclotide
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Other Names:
  • Linzess

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.
An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).
Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Collaborators

Ironwood Pharmaceuticals, Inc.

Investigators

  • Study Director: Paul Eng, PhD, Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 31, 2008

Primary Completion (ACTUAL)

January 31, 2012

Study Completion (ACTUAL)

January 31, 2012

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 2, 2008

First Posted (ESTIMATE)

October 3, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

January 24, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIN-MD-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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