Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening

This study has been completed.
Sponsor:
Information provided by:
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT00870688
First received: January 9, 2009
Last updated: May 19, 2009
Last verified: February 2009
Results First Received: January 9, 2009  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Epilepsy
Intervention: Drug: sodium valproate

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total 82 patients were included in this trial. The patients were naive or changed from another antiepileptic or valproate preparation to valproate sustained release minitablets once daily in the evening.

Reporting Groups
  Description
Sodium Valproate Epilepsy patients receive valproate sustained release minitablets, once daily.

Participant Flow:   Overall Study
    Sodium Valproate  
STARTED     82  
COMPLETED     78  
NOT COMPLETED     4  
Lost to Follow-up                 2  
Death, Unrelated                 1  
Granules in the Stools                 1  



  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.
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Reporting Groups
  Description
Sodium Valproate Epilepsy patients receive valproate sustained release minitablets, once daily.

Baseline Measures
    Sodium Valproate  
Number of Participants  
[units: participants]
  82  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     61  
>=65 years     20  
Age  
[units: years]
Mean ± Standard Deviation
  45.9  ± 23  
Gender  
[units: participants]
 
Female     43  
Male     39  



  Outcome Measures

1.  Primary:   Number of Seizures Within 7 Weeks   [ Time Frame: 7 weeks ]

2.  Primary:   Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily   [ Time Frame: 7 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Data About Efficacy, Safety and Compliance   [ Time Frame: 7 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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 NOT 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.


Results Point of Contact:  
Name/Title: Lohmueller
Organization: Desitin
phone: 0049(0)40-59101 ext 373
e-mail: lohmueller@desitin.de


No publications provided


Responsible Party: Karin Lohmueller, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00870688     History of Changes
Other Study ID Numbers: VPA 044/K
Study First Received: January 9, 2009
Results First Received: January 9, 2009
Last Updated: May 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices