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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: NCT00765999
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories

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
Chronic Constipation Irritable Bowel Syndrome With Constipation Drug: Linaclotide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1559 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
Actual Study Start Date : October 31, 2008
Actual Primary Completion Date : January 31, 2012
Actual Study Completion Date : January 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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 Name: Linzess




Primary Outcome Measures :
  1. 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).



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

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

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): NCT00765999


  Show 118 Study Locations
Sponsors and Collaborators
Forest Laboratories
Ironwood Pharmaceuticals, Inc.
Investigators
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Study Director: Paul Eng, PhD Forest Laboratories

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00765999     History of Changes
Other Study ID Numbers: LIN-MD-02
First Posted: October 3, 2008    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Forest Laboratories:
Constipation
Chronic Constipation
Irritable Bowel Syndrome With Constipation
Linaclotide

Additional relevant MeSH terms:
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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
Linaclotide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents