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Sponsored by: |
Cosmo Technologies Ltd |
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Information provided by: | Cosmo Technologies Ltd |
ClinicalTrials.gov Identifier: | NCT00867438 |
The objective of this study is to evaluate the efficacy and the tolerability of oral parnaparin sodium (210mg), administered in extended-release tablets identified as CB-01-05-MMX™.
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Procedure: Sigmoidoscopy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy and Tolerability of a New Oral Extended-Release Formulation Containing Parnaparin Sodium (CB-01-05-MMX™), Administered as Add-on Therapy to Oral Mesalazine or Other 5-ASA Derivatives, in Patients With Active, Left-Sided, Mild to Moderate Ulcerative Colitis. A Multicentre Randomized, Double-Blind, Comparative Study Versus Placebo. |
Enrollment: | 133 |
Study Start Date: | January 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator | Procedure: Sigmoidoscopy |
2: Experimental | Procedure: Sigmoidoscopy |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cosmo Technologies Ltd ( Cosmo Technologies Ltd ) |
Study ID Numbers: | CB-01-05/04 |
Study First Received: | March 20, 2009 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00867438 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
ulcerative colitis Left-sided, mild to moderate ulcerative colitis |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |