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

This study is currently recruiting participants.

Verified by Forest Laboratories, November 2008

Sponsors and Collaborators:	Forest Laboratories Ironwood Pharmaceuticals, Inc.
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00765999

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
Chronic Constipation Irritable Bowel Syndrome With Constipation	Drug: Linaclotide 300 micrograms	Phase III

MedlinePlus related topics: Constipation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Further study details as provided by Forest Laboratories:

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 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1200
Study Start Date:	October 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Linaclotide 300 micrograms Open label starting dose for all patients, optional lower dose of 150 ug per protocol criteria	Drug: Linaclotide 300 micrograms Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Eligibility

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

Criteria

Eligible patients must have entered study LIN-MD-01 and at minimum completed the pre-treatment period

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: NCT00765999

Contacts

Contact: Sandra Beaird, PhD

1-800-678-1605 ext 66297

info@forestpharm.com

Show 66 Study Locations

Sponsors and Collaborators

Forest Laboratories

Ironwood Pharmaceuticals, Inc.

More Information

Responsible Party:	Forest Research Institute ( Paul Eng, PhD, Study Director )
Study ID Numbers:	LIN-MD-02
Study First Received:	October 1, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00765999
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Forest Laboratories:

Constipation
Chronic Constipation
Irritable Bowel Syndrome With Constipation
Linaclotide

Study placed in the following topic categories:

Signs and Symptoms
Digestive System Diseases
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Constipation
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 13, 2009