A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
This will be a phase I/IIa, open-label, three-stage, single center study aimed at
investigating the safety, the efficacy (clinical and endoscopic effects) and the
pharmacokinetics of Niclosamide enema 150 mg/60 ml and 450 mg/60 ml in subjects with
mild-to-moderate UP and UPS, defined as a Modified Mayo Score (MMS) ≥ 4 and < 8, with a stool
frequency subscore (SFS) ≥ 1, a rectal bleeding sub-score (RBS) = 1 or 2, and an endoscopic
subscore (mucosal appearance) = 1 or 2. At the endoscopic sub-score any degree of friability
will be classified as having a sub-scale score of 2.