Trial Details

Authorised
Basic Information
Clinical ID c2801
Identifier EUCTR2012-005644-26-BE
Trial Title Prospective Open Label study of Parenteral vs Enteral iron in Young IBD patients and Effect on physical fitness - POPEYE study
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Anemia and fatigue in children with Inflammatory Bowel disease (IBD);Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Interventions Trade Name: Injectafer /ferinject. Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Current Sponsor code: Injectafer 50 mg/ml ijzer/ml oplossing voor injectie/infusie Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Ferrofumaraat Apotex Product Name: ferrofumaraat Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ferrous Fumarate CAS Number: 141-01-5 Current Sponsor code: ferrofumaraat Other descriptive name: FERROUS FUMARATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Participant Information
Sponsor Atrium Medical Centre
City -
Country/Region Belgium;Netherlands
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE4
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -