Phase 3
N=1,554
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Chronic Constipation · Irritable Bowel Syndrome With Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00765999 ↗Enrolled (actual)
1,554
Serious AEs
5.7%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) — 399; 748 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Linaclotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) |
399; 748 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00765999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.