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Sponsored by: |
Ironwood Pharmaceuticals, Inc. |
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Information provided by: | Ironwood Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00402337 |
The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.
Condition | Intervention | Phase |
---|---|---|
Chronic Constipation |
Drug: linaclotide acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Range-Finding, Parallel-Group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation |
Estimated Enrollment: | 300 |
Study Start Date: | November 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
75 ug linaclotide acetate: Active Comparator |
Drug: linaclotide acetate
75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.
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150 ug linaclotide acetate: Active Comparator |
Drug: linaclotide acetate
75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.
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300 ug linaclotide acetate: Active Comparator |
Drug: linaclotide acetate
75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.
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600 ug linaclotide acetate: Active Comparator |
Drug: linaclotide acetate
75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.
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Matching Placebo: Placebo Comparator |
Drug: linaclotide acetate
75, 150, 300, 600 ug linaclotide acetate administered once daily 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 |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Microbia Medical Affairs | Microbia, Inc. |
Responsible Party: | Microbia, Inc. ( Chief Medical Officer and Vice President, Clinical, Biometric, and Regulatory Affairs ) |
Study ID Numbers: | MCP-103-201 |
Study First Received: | November 18, 2006 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00402337 |
Health Authority: | United States: Food and Drug Administration |
Constipation Chronic Constipation Microbia |
linaclotide linaclotide acetate MD-1100 |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |