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More info
You can access this
clinical trial
if you have
Ulcerative Colitis, Left-sided Ulcerative Colitis or Distal Ulcerative Colitis
and you are
between 18 and 64
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: Zoenasa-1:4
  • Drug: Mesalamine Enema

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01586533. The sponsor of the trial is Altheus Therapeutics, Inc. and it is looking for 120 volunteers for the current phase.
Official trial title:
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