patients with mild to moderate left-sided ulcerative colitis
Conditions
Brief summary
the proportion of patients achieving clinical remission after 6 weeks of treatment with the test product as compared to the matching placebo. Clinical remission of ulcerative colitis is defined as a total modified Mayo score ≤2 including the following subscores: o Stool frequency subscore ≤1 o Rectal bleeding subscore = 0 o Endoscopy subscore ≤1 (score of 1 without the component “friability”).
Detailed description
to compare between treatments the proportion of patients in partial remission defined as those having an improvement in at least one clinical assessment (stool frequency subscore, rectal bleeding subscore);, the proportion of patients achieving a clinical response after 6 weeks of treatment with the test product as compared to the matching placebo, defined as: - a decrease from baseline in the modified Mayo score by ≥2 points and by at least 30% from baseline, AND - a decrease in rectal bleeding subscore ≥1 or an absolute rectal bleeding subscore of 0 or 1., the proportion of patients achieving endoscopic remission, defined as a centrally read endoscopy subscore of 0, after 6 weeks of treatment with the test product as compared to the matching placebo;, the proportion of patients achieving endoscopic improvement, defined as a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability) after 6 weeks of treatment with the test product as compared to the matching placebo;, the proportion of patients achieving urgency improvement evaluated by the urgency NRS after 1, 2, 3, 4, 5 and 6 weeks of treatment with the test product as compared to the matching placebo;, the proportion of subjects with remission in the primary endpoint and the Physician’s Global Assessment (PGA) score of ≤1 at Week 6, to compare between treatments the proportion of patients with and the number of adverse drug reactions after 6 weeks of treatment;
Interventions
DRUGRifamycin SV sodium in situ gelling solution matching placebo
(80 mL) for rectal administration
DRUGRifamycin 1% in situ gelling solution (80 mL) for rectal administration
Sponsors
Cosmo Technologies Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients achieving clinical remission after 6 weeks of treatment with the test product as compared to the matching placebo. Clinical remission of ulcerative colitis is defined as a total modified Mayo score ≤2 including the following subscores: o Stool frequency subscore ≤1 o Rectal bleeding subscore = 0 o Endoscopy subscore ≤1 (score of 1 without the component “friability”). | — |
Secondary
| Measure | Time frame |
|---|---|
| to compare between treatments the proportion of patients in partial remission defined as those having an improvement in at least one clinical assessment (stool frequency subscore, rectal bleeding subscore);, the proportion of patients achieving a clinical response after 6 weeks of treatment with the test product as compared to the matching placebo, defined as: - a decrease from baseline in the modified Mayo score by ≥2 points and by at least 30% from baseline, AND - a decrease in rectal bleeding subscore ≥1 or an absolute rectal bleeding subscore of 0 or 1., the proportion of patients achieving endoscopic remission, defined as a centrally read endoscopy subscore of 0, after 6 weeks of treatment with the test product as compared to the matching placebo;, the proportion of patients achieving endoscopic improvement, defined as a centrally read endoscopy subscore of 0 or 1 (score of 1 modified to exclude friability) after 6 weeks of treatment with the test product as compared to the matchi | — |
Countries
Bulgaria, Estonia, Hungary, Latvia, Lithuania, Poland, Romania
Outcome results
None listed