Clinical Trials in Russia - Inflammatory Bowel Disease, Anemia - Clinical Trials in Russia, www.novoclinica.com

Ferinject for Correction of Anemia in Patients With IBD (FER-IBD-COR)

Start Date ^ICMJE	October 2008
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)	Adverse events: type, nature, incidence and outcome. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] Change in disease activity (CDAI, CAI, C-reactive protein [CRP]). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] Change in different iron paramenters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Brief Title ^ICMJE	Ferinject for Correction of Anemia in Patients With IBD
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	Inflammatory Bowel Disease Anemia Iron Deficiency
Intervention ^ICMJE	Drug: Intravenous iron Intravenous infusion
Study Arms / Comparison Groups	Ferinject: Experimental Intervention: Drug: Intravenous iron Venofer: Active Comparator Intervention: Drug: Intravenous iron

Estimated Enrollment ^ICMJE

420

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Anna Ivleva Sauerborn, MD

+41 588518493

Location Countries ^ICMJE

Russian Federation