Trial Details

Not Recruiting
Basic Information
Clinical ID c3259
Identifier EUCTR2010-020448-37-NL
Trial Title Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Active Ulcerative Colitis MedDRA version: 14.1_Level: LLT_Classification code 10045365_Term: Ulcerative colitis_System Organ Class: 10017947 - Gastrointestinal disorders_;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort Pharmaceutical Form: Concentrate and diluent for solution for infusion INN or Proposed INN: Prednisolone Sodium Phosphate CAS Number: 125-02-0 Current Sponsor code: Nanocort Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 1.0 -3.2 Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use
Participant Information
Sponsor Enceladus Pharmaceuticals
City -
Country/Region Belgium;Netherlands
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -