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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396292
• Other study ID #: 1VIT03001
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2006
• Last updated: January 22, 2018
• Start date: February 2005
• Est. completion date: February 2006

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 361
• Est. completion date: February 2006
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Who Achieved 'Success' Meaning a = 2.0 Increase in Hemoglobin		anytime between baseline and the end of study or time to intervention