Status:
COMPLETED
An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Collaborating Sponsors:
Forest Laboratories
Conditions:
Irritable Bowel Syndrome With Constipation
Chronic 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).
Detailed Description
Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in doub...
Eligibility Criteria
Inclusion
- 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 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 adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
1743 Patients enrolled
Trial Details
Trial ID
NCT00730171
Start Date
September 1 2008
End Date
March 1 2012
Last Update
February 19 2018
Active Locations (116)
Enter a location and click search to find clinical trials sorted by distance.
1
Ironwood Investigational Site
Birmingham, Alabama, United States, 35209
2
Ironwood Investigational Site
Huntsville, Alabama, United States, 35801
3
Ironwood Investigational Site
Chandler, Arizona, United States, 85224
4
Ironwood Investigational Site
Phoenix, Arizona, United States, 85020