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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870688
First Posted: March 27, 2009
Last Update Posted: May 20, 2009
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:
Desitin Arzneimittel GmbH
Results First Submitted: 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.
No text entered.

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

Baseline Measures
   Sodium Valproate 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  

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


  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



Responsible Party: Karin Lohmueller, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00870688     History of Changes
Other Study ID Numbers: VPA 044/K
First Submitted: January 9, 2009
First Posted: March 27, 2009
Results First Submitted: January 9, 2009
Results First Posted: March 27, 2009
Last Update Posted: May 20, 2009