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Sponsors and Collaborators: |
Forest Laboratories Ironwood Pharmaceuticals, Inc. |
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Information provided by: | Forest Laboratories |
ClinicalTrials.gov Identifier: | NCT00765999 |
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 |
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Chronic Constipation Irritable Bowel Syndrome With Constipation |
Drug: Linaclotide 300 micrograms |
Phase III |
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 |
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 |
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1: Experimental
Linaclotide 300 micrograms Open label starting dose for all patients, optional lower dose of 150 ug per protocol criteria
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Drug: Linaclotide 300 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Eligible patients must have entered study LIN-MD-01 and at minimum completed the pre-treatment period
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandra Beaird, PhD | 1-800-678-1605 ext 66297 | info@forestpharm.com |
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 |
Constipation Chronic Constipation Irritable Bowel Syndrome With Constipation Linaclotide |
Signs and Symptoms Digestive System Diseases Signs and Symptoms, Digestive Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Constipation Intestinal Diseases Colonic Diseases, Functional |
Pathologic Processes Disease Syndrome |