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

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome With Constipation; Chronic Constipation

Treatments: Drug: Linaclotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730171

MCP-103-305

Details and patient eligibility

About

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).

Full 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).

Enrollment: 1,743 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,743 participants in 1 patient group

Linaclotide

Experimental group

Description:

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.

Treatment:

Drug: Linaclotide