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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00730171
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Constipation Chronic Constipation Drug: Linaclotide Phase 3

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  (Clinical Trial)
Actual Enrollment : 1743 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Study Start Date : September 2008
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

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 Name: Linzess



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730171


  Show 116 Study Locations
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Forest Laboratories
Investigators
Study Chair: Jeffrey M. Johnston, MD, FACP Ironwood Pharmaceuticals, Inc.

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00730171     History of Changes
Other Study ID Numbers: MCP-103-305
First Posted: August 8, 2008    Key Record Dates
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases