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

This study has been completed.
Sponsor:
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00765999
First received: October 1, 2008
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Chronic Constipation
Irritable Bowel Syndrome With Constipation
 Drug: Linaclotide 300 micrograms
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Constipation
Drug Information available for: Linaclotide
U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1557
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765999

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

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00765999     History of Changes
Other Study ID Numbers: LIN-MD-02
Study First Received: October 1, 2008
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on June 13, 2013