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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

361 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-02-28

Brief Summary

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

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Detailed Description

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

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

VIT-45

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Oral iron tablets

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Ferrous Sulfate

Eligibility Criteria

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Inclusion Criteria

* Female Subjects able to give consent
* Post partum patients
* Baseline Hbg\< /= 10
* Agree to practice birth control
* Demonstrate willingness to comply with protocol restrictions

Exclusion Criteria

* Known hypersensitivity reaction to oral or IV iron (VIT-45)
* Documented history of discontinuing oral iron
* Significant bleeding
* History of anemia other that iron deficiency anemia
* Severe Psychiatric disorders
* Active severe infection
* Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
* Known HIV antibody
* Received investigational product within 30 days
* Alcohol abuse
* Hemochromatosis or other iron storage disorder

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No