Trial Details
Not RecruitingBasic Information
| Clinical ID | c5125 |
|---|---|
| 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 | NULL |
|---|---|
| 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] - Digesti |
| Interventions | Product Name: PEG-liposomal prednisolone sodium phosphateProduct Code: NanocortPharmaceutical Form: Concentrate and diluent for solution for infusionINN or Proposed INN: Prednisolone Sodium PhosphateCAS Number: 125-02-0Current Spon |
Participant Information
| Sponsor | Enceladus Pharmaceuticals |
|---|---|
| City | NULL |
| Country/Region | Belgium;Netherlands |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | NULL |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | NULL |
Time Information
| Start Date | NULL |
|---|---|
| Primary Completion Date | NULL |
| Completion Date | NULL |