Status:
COMPLETED
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Lead Sponsor:
Forest Laboratories
Collaborating Sponsors:
Ironwood Pharmaceuticals, Inc.
Conditions:
Chronic Constipation
Irritable Bowel Syndrome With Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- Patients must have
- entered study LIN-MD 01\[NCT00765882\] or LIN-MD-31 \[NCT00948818\] and at minimum completed the pre-treatment period or
- completed one of the following studies: MCP-103-004 \[NCT00306748\], MCP-103-005 \[NCT00258193\], MCP-103-201 \[NCT00402337\], MCP-103-202 \[NCT00460811\]
- 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 CC or IBS-C
Exclusion
- 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 ECG, or clinical laboratory test
Key Trial Info
Start Date :
October 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2012
Estimated Enrollment :
1559 Patients enrolled
Trial Details
Trial ID
NCT00765999
Start Date
October 31 2008
End Date
January 31 2012
Last Update
February 15 2019
Active Locations (118)
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1
Innovative Clinical Trials
Birmingham, Alabama, United States, 35205
2
Parkway Medical Center
Birmingham, Alabama, United States, 35215
3
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
4
Radiant Research, Inc.
Chandler, Arizona, United States, 85224