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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:
ClinicalTrials.gov Identifier:
NCT00765999
First Posted: October 3, 2008
Last Update Posted: January 15, 2013
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.
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories
  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
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

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  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): NCT00765999


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

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00765999     History of Changes
Other Study ID Numbers: LIN-MD-02
First Submitted: October 1, 2008
First Posted: October 3, 2008
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


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