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Completed

NCT Number: NCT00396292

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

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

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral iron tablets

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

Other names: Ferrous Sulfate

VIT-45

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

Primary outcomes

  1. Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin

    Time frame: anytime between baseline and the end of study or time to intervention

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2006
First posted
Nov 6, 2006
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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