An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Phase 3

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Linaclotide	Linaclotide	Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)	Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.	An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).

Secondary Outcome Measures

Name	Time	Method

Locations (109): Innovative Clinical Trials
🇺🇸
Birmingham, Alabama, United States
Parkway Medical Center
🇺🇸
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc.
🇺🇸
Huntsville, Alabama, United States
Radiant Research, Inc.
🇺🇸
Lakewood, Washington, United States
Pivotal Research Centers
🇺🇸
Peoria, Arizona, United States
Pivotal Research Center
🇺🇸
Peoria, Arizona, United States
Carl T Hayden VA Medical Center GI Section-CS-111G
🇺🇸
Phoenix, Arizona, United States
Elite Clinical Studies, LLC
🇺🇸
Phoenix, Arizona, United States
Genova Clinical Research, Inc.
🇺🇸
Tucson, Arizona, United States
Adobe Clinical Research, LLC
🇺🇸
Tucson, Arizona, United States
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Innovative Clinical Trials
🇺🇸Birmingham, Alabama, United States