NCT00396292

Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia

Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Detailed description

This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Oral iron tablets	325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
DRUG	VIT-45	A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-11-01
• Completion: 2006-02-01
• First posted: 2006-11-06
• Last updated: 2018-02-05
• Results posted: 2013-12-10

Locations

1 site across 1 country: United States