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Phenytoin and Multidose Activated Charcoal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brent W Morgan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00823264
First received: January 14, 2009
Last updated: September 4, 2014
Last verified: September 2014
Results First Received: August 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Phenytoin Toxicity
Intervention: Drug: Activated Charcoal

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Will not receive activated charcoal. Serum levels will be followed.
Multiple Doses of Activated Charcoal Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is < 25 ug/cc.

Participant Flow:   Overall Study
    Control     Multiple Doses of Activated Charcoal  
STARTED     10     7  
COMPLETED     8     7  
NOT COMPLETED     2     0  
Protocol Violation                 2                 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.
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Reporting Groups
  Description
Control Will not receive activated charcoal. Serum levels will be followed.
Multiple Doses of Activated Charcoal Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are < 25 ug/cc.
Total Total of all reporting groups

Baseline Measures
    Control     Multiple Doses of Activated Charcoal     Total  
Number of Participants  
[units: participants]
  8     7     15  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     7     14  
>=65 years     1     0     1  
Gender  
[units: participants]
     
Female     0     0     0  
Male     8     7     15  
Region of Enrollment  
[units: participants]
     
United States     8     7     15  



  Outcome Measures

1.  Primary:   Time of Elimination of Phenytoin in Patients With Elevated Phenytoin Levels   [ Time Frame: Serum phenytoin levels were obtained every 6 hours for 24 hours then once every 24 hours ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Brent Morgan
Organization: Emory University
phone: 404-616-4403
e-mail: bmorg02@emory.edu


Publications of Results:

Responsible Party: Brent W Morgan, MD, Emory University
ClinicalTrials.gov Identifier: NCT00823264     History of Changes
Other Study ID Numbers: IRB00008017
Study First Received: January 14, 2009
Results First Received: August 14, 2013
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board