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

This study has been completed.

First Received on August 5, 2008. Last Updated on March 16, 2012 History of Changes

Sponsor:	Ironwood Pharmaceuticals, Inc.
Collaborator:	Forest Laboratories
Information provided by (Responsible Party):	Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00730171

Purpose

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)

Condition	Intervention	Phase
Irritable Bowel Syndrome With Constipation Chronic Constipation	Drug: Linaclotide	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation

U.S. FDA Resources

Further study details as provided by Ironwood Pharmaceuticals, Inc.:

Primary Outcome Measures:

Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements. [ Time Frame: Entire study participation, up to 78 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Treatment Satisfaction [ Time Frame: Study Visits ] [ Designated as safety issue: No ]

Estimated Enrollment:	1750
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Linaclotide Oral, once daily	Drug: Linaclotide Oral, once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 chronic constipation (CC) or irritable bowel syndrome with constipation (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 electrocardiogram (ECG), or clinical laboratory test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730171

Show 116 Study Locations

Sponsors and Collaborators

Ironwood Pharmaceuticals, Inc.

Forest Laboratories

Investigators

Study Chair:

Jeffrey M. Johnston, MD, FACP

Ironwood Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00730171 History of Changes
Other Study ID Numbers:	MCP-103-305
Study First Received:	August 5, 2008
Last Updated:	March 16, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional

Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2012