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

January 19, 2018 updated by: Ironwood Pharmaceuticals, Inc.

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

Detailed Description

Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).

Study Type

Interventional

Enrollment (Actual)

1743

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Ironwood Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Ironwood Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Investigational Site
      • Phoenix, Arizona, United States, 85020
        • Ironwood Investigational Site
      • Tucson, Arizona, United States, 85710
        • Ironwood Investigational Site
      • Tucson, Arizona, United States, 85715
        • Ironwood Investigational Site
      • Tucson, Arizona, United States, 85741
        • Ironwood Investigational Site
    • Arkansas
      • Sherwood, Arkansas, United States, 72120
        • Ironwood Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Ironwood Investigational Site
      • Chula Vista, California, United States, 91910
        • Ironwood Investigational Site
      • Encinitas, California, United States, 92024
        • Ironwood Investigational Site
      • Garden Grove, California, United States, 92840
        • Ironwood Investigational Site
      • Laguna Hills, California, United States, 92653
        • Ironwood Investigational Site
      • Los Angeles, California, United States, 90045
        • Ironwood Investigational Site
      • Orange, California, United States, 92868
        • Ironwood Investigational Site
      • Sacramento, California, United States, 95830
        • Ironwood Investigational Site
      • San Carlos, California, United States, 94070
        • Ironwood Investigational Site
      • San Diego, California, United States, 92103
        • Ironwood Investigational Site
      • San Diego, California, United States, 92108
        • Ironwood Investigational Site
      • San Diego, California, United States, 92123
        • Ironwood Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Ironwood Investigational Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Ironwood Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Ironwood Investigational Site
      • Hollywood, Florida, United States, 33021
        • Ironwood Investigational Site
      • Inverness, Florida, United States, 34452
        • Ironwood Investigational Site
      • Jacksonville, Florida, United States, 32205
        • Ironwood Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Ironwood Investigational Site
      • Lauderdale Lakes, Florida, United States, 33319
        • Ironwood Investigational Site
      • Miami, Florida, United States, 33156
        • Ironwood Investigational Site
      • Pinellas Park, Florida, United States, 33782
        • Ironwood Investigational Site
      • Port Orange, Florida, United States, 32129
        • Ironwood Investigational Site
      • Tampa, Florida, United States, 33607
        • Ironwood Investigational Site
    • Georgia
      • Newnan, Georgia, United States, 30263
        • Ironwood Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61602
        • Ironwood Investigational Site
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Ironwood Investigational Site
    • Iowa
      • Clive, Iowa, United States, 50325
        • Ironwood Investigational Site
      • Davenport, Iowa, United States, 52807
        • Ironwood Investigational Site
    • Kansas
      • Mission, Kansas, United States, 66202
        • Ironwood Investigational Site
      • Overland Park, Kansas, United States, 66215
        • Ironwood Investigational Site
      • Topeka, Kansas, United States, 66606
        • Ironwood Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Ironwood Investigational Site
      • Metairie, Louisiana, United States, 70006
        • Ironwood Investigational Site
      • Monroe, Louisiana, United States, 71201
        • Ironwood Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • Ironwood Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Ironwood Investigational Site
      • Baltimore, Maryland, United States, 21215
        • Ironwood Investigational Site
      • Hollywood, Maryland, United States, 20636
        • Ironwood Investigational Site
      • Laurel, Maryland, United States, 20707
        • Ironwood Investigational Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Ironwood Investigational Site
      • Traverse City, Michigan, United States, 49684
        • Ironwood Investigational Site
      • Troy, Michigan, United States, 48098
        • Ironwood Investigational Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Ironwood Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Ironwood Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • Ironwood Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Ironwood Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89104
        • Ironwood Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Ironwood Investigational Site
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 07927
        • Ironwood Investigational Site
      • Marlton, New Jersey, United States, 08053
        • Ironwood Investigational Site
      • Ocean City, New Jersey, United States, 07712
        • Ironwood Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Ironwood Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • Ironwood Investigational Site
      • Pittsford, New York, United States, 14534
        • Ironwood Investigational Site
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Ironwood Investigational Site
      • Asheville, North Carolina, United States, 28801
        • Ironwood Investigational Site
      • Chapel Hill, North Carolina, United States, 27599
        • Ironwood Investigational Site
      • Charlotte, North Carolina, United States, 28211
        • Ironwood Investigational Site
      • Greensboro, North Carolina, United States, 27408
        • Ironwood Investigational Site
      • Harrisburg, North Carolina, United States, 28075
        • Ironwood Investigational Site
      • Hickory, North Carolina, United States, 28602
        • Ironwood Investigational Site
      • Huntersville, North Carolina, United States, 28078
        • Ironwood Investigational Site
      • Jacksonville, North Carolina, United States, 28546
        • Ironwood Investigational Site
      • New Bern, North Carolina, United States, 28562
        • Ironwood Investigational Site
      • Statesville, North Carolina, United States, 28625
        • Ironwood Investigational Site
      • Summerville, North Carolina, United States, 29485
        • Ironwood Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Ironwood Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Ironwood Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Ironwood Investigational Site
      • Cincinnati, Ohio, United States, 45224
        • Ironwood Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • Ironwood Investigational Site
      • Dayton, Ohio, United States, 45440
        • Ironwood Investigational Site
      • Mentor, Ohio, United States, 44060
        • Ironwood Investigational Site
      • Sylvania, Ohio, United States, 43560
        • Ironwood Investigational Site
      • Wadsworth, Ohio, United States, 44281
        • Ironwood Investigational Site
      • Zanesville, Ohio, United States, 43701
        • Ironwood Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Ironwood Investigational Site
      • Yukon, Oklahoma, United States, 73099
        • Ironwood Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Ironwood Investigational Site
      • Lancaster, Pennsylvania, United States, 19606
        • Ironwood Investigational Site
      • Levittown, Pennsylvania, United States, 19056
        • Ironwood Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Ironwood Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Ironwood Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Ironwood Investigational Site
      • Charleston, South Carolina, United States, 29414
        • Ironwood Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • Ironwood Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Ironwood Investigational Site
      • Chattanooga, Tennessee, United States, 37421
        • Ironwood Investigational Site
      • Germantown, Tennessee, United States, 38138
        • Ironwood Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Ironwood Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Ironwood Investigational Site
    • Texas
      • Beaumont, Texas, United States, 77701
        • Ironwood Investigational Site
      • El Paso, Texas, United States, 79905
        • Ironwood Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Ironwood Investigational Site
      • Houston, Texas, United States, 77024
        • Ironwood Investigational Site
      • Irving, Texas, United States, 75061
        • Ironwood Investigational Site
      • Longview, Texas, United States, 75605
        • Ironwood Investigational Site
      • San Antonio, Texas, United States, 78229
        • Ironwood Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Ironwood Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Ironwood Investigational Site
      • Salt Lake City, Utah, United States, 84107
        • Ironwood Investigational Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Ironwood Investigational Site
      • Lynchburg, Virginia, United States, 24502
        • Ironwood Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • Ironwood Investigational Site
      • Vancouver, Washington, United States, 98664
        • Ironwood Investigational Site
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Ironwood Investigational Site
      • Milwaukee, Wisconsin, United States, 53215
        • Ironwood Investigational Site

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 MCP-103-303 or MCP-103-302 and at minimum completed the pre-treatment period or
    • completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201, MCP-103-202
  • 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 adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Linaclotide
Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.
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 Event (TEAE)
Time Frame: From first dose of open-label study drug up to 78 weeks
For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug.
From first dose of open-label study drug up to 78 weeks

Collaborators and Investigators

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

Sponsor

Ironwood Pharmaceuticals, Inc.

Collaborators

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

September 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 5, 2008

First Submitted That Met QC Criteria

August 5, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCP-103-305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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