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Birmingham, Alabama 35205

  • Irritable Bowel Syndrome With Constipation


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).


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

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Forest Laboratories

Oversight Authority:

  • United States: Food and Drug Administration
  • Canada: Health Canada

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Paul Eng, PhD
Study Director
Forest Laboratories

Study Dates

Start Date:October 31, 2008
Completion Date:January 31, 2012
Completion Type:Actual
Primary Completion Date:January 31, 2012
Primary Completion Type:Actual
Verification Date:January 2019
Last Changed Date:January 24, 2019
First Received Date:October 1, 2008
First Results Date:September 19, 2017

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Description:Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Arm Name:Linaclotide
Other Name:Linzess

Study Arms

Study Arm Type:Experimental
Arm Name:Linaclotide
Description: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 o

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Forest Laboratories
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Ironwood Pharmaceuticals, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: March 30, 2020

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