Trial Details

Not Recruiting
Basic Information
Clinical ID c3289
Identifier EUCTR2009-012544-16-GB
Trial Title A phase III, randomized, comparative, open-label study of intravenous iron oligosaccharide (Monofer) administered by infusions or repeated bolus injections in comparison with oral iron sulphate in inflammatory bowel disease subjects with iron deficiency anaemia - P-Monofer-IBD-01
Trial URL Visit Original Page
Study Information
Study Results

Yes
Conditions Inflammatory bowel disease subjects with iron deficiency anaemia _ MedDRA version: 9.1_ Level: LLT_ Classification code 10022972_ Term: Iron Deficiency anaemia_ _ MedDRA version: 9.1_ Level: LLT_ Classification code 10021972_ Term: Inflammatory bowel disease_
Interventions Trade Name: MonoFer Product Name: Monofer 100 mg/ml Pharmaceutical Form: Solution for infusion INN or Proposed INN: Iron oligosaccharide complex CAS Number: 9004-66-4 Other descriptive name: Iron isomalto-oligosaccharide complex Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Trade Name: Ferro Duretter, prolonged release tablet Product Name: Ferro Duretter, prolonged release tablet Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Iron Sulphate
Participant Information
Sponsor Pharmacosmos A/S
City -
Country/Region Hungary;Austria;Denmark;United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date 2016-03-30
Completion Date 2012-07-30