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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: NCT00730171
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : January 8, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1743 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 : September 2008
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Linaclotide
Oral, once daily
Drug: Linaclotide
Oral, once daily


Outcome Measures

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 78 weeks ]

Secondary Outcome Measures :
  1. Treatment Satisfaction [ Time Frame: Study Visits ]

Eligibility Criteria

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 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

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): 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

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00730171     History of Changes
Other Study ID Numbers: MCP-103-305
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

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