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A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis
This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion.
Details
| Lead sponsor | Altheus Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 120 |
| Start date | 2012-06 |
Conditions
- Ulcerative Colitis
- Left-sided Ulcerative Colitis
- Distal Ulcerative Colitis
Interventions
- Zoenasa-1:4
- Mesalamine Enema
Primary outcomes
- Change in modified UCDAI at 6 weeks — 6 weeks
Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 6 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine
Countries
United States