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

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ClinicalTrials.gov Identifier: NCT00765999
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : January 15, 2013
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 300 micrograms Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1557 participants
Allocation: Non-Randomized
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 : October 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Linaclotide 300 micrograms Open label starting dose for all patients, optional lower dose of 150 ug per protocol criteria
Drug: Linaclotide 300 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study



Primary Outcome Measures :
  1. Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements. [ Time Frame: Entire study participation, up to 52 weeks ]


Information from the National Library of Medicine

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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 LIN-MD-01 or LIN-MD-31 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 chronic constipation (CC) or irritable bowel syndrome with constipation (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 event (AE) or a clinically significant finding on a physical examination, 12-lead electrocardiogram (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
Study Director: Paul Eng, PhD Forest Laboratories

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
Last Update Posted: January 15, 2013
Last Verified: January 2013

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

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