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.
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: October 1, 2008
Last updated: January 11, 2013
Last verified: January 2013

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:

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00765999

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

No publications provided

Responsible Party: Forest Laboratories 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:
Chronic Constipation
Irritable Bowel Syndrome With Constipation

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on April 20, 2014