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.
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
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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
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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