An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
| Status: | Completed |
|---|---|
| Conditions: | Constipation, Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | October 31, 2008 |
| End Date: | January 31, 2012 |
An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
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).
patients with chronic constipation (CC) or irritable bowel syndrome with constipation
(IBS-C).
Inclusion Criteria:
- 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 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 ECG, or clinical laboratory test
We found this trial at
110
sites
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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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