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

Study Overview
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Brief Summary
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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).

Official Title
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An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Conditions
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Chronic Constipation, Irritable Bowel Syndrome With Constipation

Intervention / Treatment
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* Drug: Linaclotide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linaclotide<br>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. | Drug: Linaclotide<br>* Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.<br>* Other names: Linzess;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) | 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). | Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Chronic Constipation, Irritable Bowel Syndrome With Constipation, Linaclotide