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

This study has been completed.

Sponsored by:	Luitpold Pharmaceuticals
Information provided by:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00396292

Purpose

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

Condition	Intervention	Phase
Anemia	Drug: Intravenous Iron Drug: Oral Iron	Phase III

MedlinePlus related topics: Anemia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:

Number of patients classified as "success"

Secondary Outcome Measures:

Time to Clinical success designation
Change in Hgb
Change in Iron indices

Enrollment:	352
Study Start Date:	December 2004
Study Completion Date:	November 2005

Detailed Description:

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

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396292

Locations

United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403

Sponsors and Collaborators

Luitpold Pharmaceuticals

Investigators

Study Director:

Antoinette Mangione, MD, PharmD

Luitpold Pharmaceuticals

More Information

Publications of Results:

Baker JB, Seid MH, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Postpartum Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.

Baker JB, Seid MH, Van Wyck DB, Dinh Q. Ferric Carboxymaltose, a New IV Iron Agent for Treating Postpartum Women with Iron Deficiency Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.

Publications indexed to this study:

Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78.

Study ID Numbers:	1VIT03001
Study First Received:	November 2, 2006
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00396292
Health Authority:	United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:

Anemia
postpartum
Postpartum anemia

Study placed in the following topic categories:

Hematologic Diseases
Anemia
Iron

Additional relevant MeSH terms:

Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009