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:
Forest Laboratories
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00730171
First received: August 5, 2008
Last updated: January 7, 2013
Last verified: January 2013
  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
Irritable Bowel Syndrome With Constipation
Chronic Constipation
Drug: Linaclotide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Ironwood Pharmaceuticals, Inc.:

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 78 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Treatment Satisfaction [ Time Frame: Study Visits ] [ Designated as safety issue: No ]

Enrollment: 1743
Study Start Date: September 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linaclotide
Oral, once daily
Drug: Linaclotide
Oral, once daily

  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 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 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 AE or a clinically significant finding on a physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730171

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

No publications provided

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00730171     History of Changes
Other Study ID Numbers: MCP-103-305
Study First Received: August 5, 2008
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014