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

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome With Constipation; Chronic Constipation
• Interventions: Drug: Linaclotide

• Registration Number: NCT00730171
• Lead Sponsor: Ironwood Pharmaceuticals, Inc.

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).

Detailed Description

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).

Study Timeline

• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-08
• Study Start: 2008-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2017-12-18
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-19
• Last Update Submitted: 2018-01-19
• Results First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1743

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Linaclotide	Linaclotide	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	From first dose of open-label study drug up to 78 weeks	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.

Trial Locations

Locations (1)

Ironwood Investigational Site; 🇺🇸 Milwaukee, Wisconsin, United States