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Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

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ClinicalTrials.gov Identifier: NCT00548860
Recruitment Status : Completed
First Posted : October 24, 2007
Results First Posted : May 29, 2015
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals

Brief Summary:
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.

Condition or disease Intervention/treatment Phase
Anemia Drug: Ferric Carboxymaltose Drug: Standard Medical Care (SMC) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2018 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
Study Start Date : October 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ferric Carboxymaltose (FCM)
Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)
Drug: Ferric Carboxymaltose
Active Comparator: Standard Medical Care (SMC)
Varied as determined by the Investigator
Drug: Standard Medical Care (SMC)



Primary Outcome Measures :
  1. Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC. [ Time Frame: From Day 0 through 30 days after the last dose of study drug. ]
    Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female with iron deficiency anemia
  • Hg </= 11 g/dL

Exclusion Criteria:

  • Previous participation in a FCM trial
  • Known Hypersensitivity to FCM
  • History of anemia other that anemia due to heavy uterine bleeding or the post partum state
  • current history of GI bleeding
  • Received IV Iron within the month prior
  • Anticipated need for surgery
  • Malignancy history
  • AST or ALT greater than normal
  • Received an investigational drug within 30 days of screening
  • Pregnant or sexually active females who are not willing ot use an effective form of birth control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548860


Locations
United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00548860     History of Changes
Other Study ID Numbers: 1VIT07017
First Posted: October 24, 2007    Key Record Dates
Results First Posted: May 29, 2015
Last Update Posted: February 20, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Uterine Hemorrhage
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Ferric Compounds
Hematinics