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).

Detailed Description
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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 double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).

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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Irritable Bowel Syndrome With Constipation, Chronic 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 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 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 adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, 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. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator. | 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 Event (TEAE) | For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug. | From first dose of open-label study drug up to 78 weeks |