Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01382901
First received: February 23, 2011
Last updated: July 8, 2011
Last verified: July 2011
Results First Received: February 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Restless Legs Syndrome (RLS)
Interventions: Drug: Ferric Carboxymaltose (FCM)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study Period: March 23, 2006 to July 16, 2007 Locations: Hospitals and Medical Clinics (15 total sites)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ferric Carboxymaltose (FCM) 2 x 500 mg 500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Placebo Intravenous (IV) solution of placebo on Day 0 and Day 5.

Participant Flow:   Overall Study
    Ferric Carboxymaltose (FCM) 2 x 500 mg     Placebo  
STARTED     24     21  
COMPLETED     7     7  
NOT COMPLETED     17     14  



  Baseline Characteristics
  Hide Baseline Characteristics

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) 2 x 500 mg 500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
Placebo Intravenous (IV) solution of placebo on Day 0 and Day 5.
Total Total of all reporting groups

Baseline Measures
    Ferric Carboxymaltose (FCM) 2 x 500 mg     Placebo     Total  
Number of Participants  
[units: participants]
  24     21     45  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     15     35  
>=65 years     4     6     10  
Age  
[units: years]
Mean ± Standard Deviation
  49.5  ± 11.42     54.1  ± 13.68     51.7  ± 12.59  
Gender  
[units: participants]
     
Female     17     11     28  
Male     7     10     17  
Region of Enrollment  
[units: participants]
     
United States     24     21     45  



  Outcome Measures

1.  Primary:   International Restless Legs Syndrome (IRLS) Total Score   [ Time Frame: Change from Baseline to Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 more than 60 days but less than or equal to 180 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: Marc Tokars
Organization: Luitpold Pharmaceuticals, Inc.
phone: 601-650-4200 ext 805
e-mail: mtokars@lpicrd.com


No publications provided


ClinicalTrials.gov Identifier: NCT01382901     History of Changes
Other Study ID Numbers: 1VIT05009
Study First Received: February 23, 2011
Results First Received: February 23, 2011
Last Updated: July 8, 2011
Health Authority: United States: Food and Drug Administration