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Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307007
First Posted: March 2, 2011
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
Results First Submitted: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Iron Deficiency Anemia
Interventions: Drug: Ferric Carboxymaltose (FCM)
Drug: Iron Dextran Injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Hospitals and medical clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the FCM group, reasons for discontinuation prior to dosing included lost to follow-up (5 subjects), subject request (2 subjects), and selection criteria/study compliance (2 subjects). In the iron dextran group, reasons for discontinuation prior to dosing included subject request (4 subjects) and lost to follow-up (1 subject).

Reporting Groups
  Description
Ferric Carboxymaltose (FCM) Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
Iron Dextran Injection Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.

Participant Flow:   Overall Study
    Ferric Carboxymaltose (FCM)   Iron Dextran Injection
STARTED   25   30 
COMPLETED   25   30 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ferric Carboxymaltose (FCM) Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
Iron Dextran Injection Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
Total Total of all reporting groups

Baseline Measures
   Ferric Carboxymaltose (FCM)   Iron Dextran Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   30   55 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      25 100.0%      30 100.0%      55 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.8  (10.26)   33.7  (10.72)   35.1  (10.54) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25 100.0%      30 100.0%      55 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   25   30   55 


  Outcome Measures

1.  Primary:   Changes in Blood Markers   [ Time Frame: Day 35 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sumita Chowdhury, MD, MPH, FACC, MBA
Organization: Luitpold Pharmaceuticals, Inc.
phone: 610-650-4200
e-mail: SChowdhury@lpicrd.com


Publications of Results:

Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01307007     History of Changes
Other Study ID Numbers: 1VIT08023
First Submitted: October 4, 2010
First Posted: March 2, 2011
Results First Submitted: July 22, 2015
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017