Ferinject for Correction of Anemia in Patients With IBD (FER-IBD-COR)
Tracking Information
Start Date ICMJE | October 2008 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: December 16, 2008) | Number of responders [ Time Frame: at Week 12 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE (submitted: December 16, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Ferinject for Correction of Anemia in Patients With IBD |
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Official Title ICMJE | |
Brief Summary | The aim of the study is to evaluate the efficacy and safety of a new dosage regimen of FERINJECT® compared with a well established intravenous iron treatment. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE | Drug: Intravenous iron Intravenous infusion |
Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 420 | ||||
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Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Russian Federation |
Administrative Information
Source: http://clinicaltrials.gov/