IBD Research Resource Center

Clinical ID	c3224
Identifier	EUCTR2010-023797-39-GB
Trial Title	TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD.
Trial URL	Visit Original Page

Study Results	Yes
Conditions	Inflammatory bowel disease _ MedDRA version: 14.1_ Level: LLT_ Classification code 10045365_ Term: Ulcerative colitis_ System Organ Class: 10017947 - Gastrointestinal disorders_ _ MedDRA version: 14.1_ Level: PT_ Classification code 10011401_ Term: Crohn's disease_ System Organ Class: 10017947 - Gastrointestinal disorders_
Interventions	Trade Name: Iron sulphate 200mg coated tablets Product Name: Ferrous sulphate Product Code: Ferrous sulphate Pharmaceutical Form: Tablet INN or Proposed INN: Iron sulphate CAS Number: 7720-78-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: CosmoFer Product Name: CosmoFer 50mg/ml solution for infusion or injection Pharmaceutical Form: Solution for infusion INN or Proposed INN: iron(III)- hydroxide dextran complex CAS Number: 9004-66-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50-

Sex Requirement	ALL
Age Requirement	-

Study Type	Interventional clinical trial of medicinal product
Phase	PHASE4