Trial Details

Not Recruiting
Basic Information
Clinical ID c3272
Identifier CTRI/2009/091/000983
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 Study ID: P-Monofer-IBD-01 - Nil
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions Health Condition 1: null- Iron Deficiency Anemia in Inflammatory Bowel Disease Subjects ___
Interventions Intervention1: Iron oligosaccharide (Monofer: Study Drug: Administered as intravenous infusions (A1) upto 1000 mg at a time until total iron repletion is achieved. Administered as intravenous bolus injections (A2) as repeated bolus injections 500mg weekly until total iron repletion is achieved. Control Intervention1: Iron Sulphate: Oral, 100 mg elemental Iron 2 times a day for 8 weeks.
Participant Information
Sponsor Pharmacosmos AS
City -
Country/Region India;Austria;Denmark;Hungary
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional
Phase PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -