Status:
COMPLETED
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00396292
Start Date
February 1 2005
End Date
February 1 2006
Last Update
February 5 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403