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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00396292 |
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Date of registration:
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02/11/2006 |
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Primary sponsor: |
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Public title:
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Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia
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Scientific title:
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Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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352 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00396292 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Antoinette Mangione, MD, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Luitpold Pharmaceuticals |
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Key inclusion & exclusion 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
- 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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: Intravenous Iron
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Drug: Oral Iron
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Primary Outcome(s)
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Number of patients classified as "success"
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Secondary Outcome(s)
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Change in Hgb
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Change in Iron indices
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Time to Clinical success designation
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Secondary ID(s)
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1VIT03001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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