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Trial record 33 of 89 for:    CARBAMAZEPINE AND Psychotropic

Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.

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.
 
ClinicalTrials.gov Identifier: NCT00260247
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : April 22, 2015
Sponsor:
Collaborators:
Danish Research Agency
Novartis
Information provided by:
Odense University Hospital

Tracking Information
First Submitted Date  ICMJE November 28, 2005
First Posted Date  ICMJE December 1, 2005
Last Update Posted Date April 22, 2015
Study Start Date  ICMJE April 2005
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
Formation clearance of 3-hydroxyquinidine
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
Ratio of metabolite to drug AUC's of 3-OH quinidine to quinidine.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
Official Title  ICMJE Induction of Drug Metabolism: A Comparative, Pharmacokinetic in Vivo Study of the Effect of Carbamazepine and Oxcarbazepine on CYP3A4.
Brief Summary

This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.

This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.

It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Clearance Rate
Intervention  ICMJE Drug: carbamazepine oxcarbazepine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2005)
10
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI < 30
  • Non smoker
  • No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
  • Informed consent

Exclusion Criteria:

  • signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
  • mental disease
  • participation in another clinical trial involving drugs with 3 months of randomization
  • donation of more than 500 mL blood within 3 months of randomization
  • intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00260247
Other Study ID Numbers  ICMJE AKF-315
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE
  • Danish Research Agency
  • Novartis
Investigators  ICMJE
Principal Investigator: Per Damkier, MD, Ph.D. Odense University Hospital
PRS Account Odense University Hospital
Verification Date March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP