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

Recruiting Phase 2 Phase 3 Interventional Study
Ulcerative Colitis, Unspecified
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
459 (estimated)
Sponsor
University Hospital Schleswig-Holstein · Other
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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 sup…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: General: 1. Male and female patients with UC and 18 to 80 years of age (at the time of signing the informed consent). 2. Ability to understand and comply with the protocol. 3. Signed written informed consent. Disease-specific: 4. Documented diagnosis of UC, with a minimum d…
Contacts

Stefan Schreiber, Prof. Dr. Dr. hc.

+4943150022200

s.schreiber@mucosa.de

CONTACT

Friso Muijsers

+4943150030751

info@zks.uni-kiel.de

CONTACT