Overview

Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients with Mild to Moderately Active Ulcerative Colitis

Status:
RECRUITING

Trial end date:
2027-12-01

Target enrollment:

Participant gender:

Summary

Double-blind, randomised, placebo-controlled phase II / III trial evaluating efficacy and safety of two different doses (2 g/d or 3 g/d) of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to placebo in patients with ulcerative colitis (UC). The intended therapeutic use of CICR-NAM is to improve intestinal inflammation in adults with UC by topically increasing nicotinamide supply in the ileocolonic region and thus favourably influencing the composition of intestinal microbiota

Phase:

PHASE2

Details

Lead Sponsor:

University Hospital Schleswig-Holstein

Collaborators:

Ced Service GmbH
German Federal Ministry of Education and Research
Gesellschaft für Therapieforschung mbH