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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Zoenasa Rectal Gel (4.0g mesalamine \[5-ASA\], 1.0g N-acetylcysteine \[NAC\]; 60ml)
Mesalamine Rectal Suspension Enema (4.0g mesalamine \[5-ASA\], 60ml)
Birmingham Gastroenterology Associates
Birmingham, Alabama, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Rocky Mountain Gastroenterology
Lakewood, Colorado, United States
Digestive Disease Associates
Gainesville, Florida, United States
Digestive Medical Associates
Hialeah, Florida, United States
Change in modified UCDAI at 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
Time frame: 6 weeks
Change in modified UCDAI at 3 weeks
Change from baseline in the modified Ulcerative Colitis Disease Activity Index (modified UCDAI) score at the end of the 3 week treatment period of Zoenasa™ Rectal Gel compared with mesalamine
Time frame: 3 weeks
Clinical and endoscopic remission rates at 6 weeks
Proportion of patients in clinical and endoscopic remission at 6 weeks compared to baseline
Time frame: 6 weeks
Clinical and endoscopic remission rates at 3 weeks
Proportion of patients in clinical and endoscopic remission at 3 weeks compared to baseline
Time frame: 3 weeks
Clinical improvement rate after 6 weeks
Time frame: 6 weeks
Clinical improvement rate after 3 weeks
Time frame: 3 weeks
Endoscopic improvement rate at 6 weeks
Time frame: 6 weeks
Endoscopic improvement rate at 3 weeks
Time frame: 3 weeks
Change from baseline in endoscopic appearance after 6 weeks
Time frame: 6 weeks
Change from baseline in endoscopic appearance after 3 weeks
Time frame: 3 weeks
Time to resolution of rectal bleeding
Time frame: Up to 6 weeks
Relapse rates at 6 weeks
Time frame: 6 weeks
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The Center for Gastrointestinal Disorders
Hollywood, Florida, United States
Miami Gastroenterology Consultants P.A.
Miami, Florida, United States
South Medical Research Group
Miami, Florida, United States
Gastroenterology of Naples
Naples, Florida, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, United States
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