Healthy Subjects Clinical Trial
Verified date | March 2014 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Observational |
Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine
Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung
moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie
schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder
diabetischer Polyneuropathie).
In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich
ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal®
(Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt.
Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der
Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen
Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon®
die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der
Haut vermindert werden.
- Trial with medicinal product
Status | Completed |
Enrollment | 24 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion criteria: Male - Age: 18-65 years - Weight: 50 - 100 kg - Height: 155 - 195 cm - Signed and dated informed consent Exclusion criteria: - Contraindications to the class of drugs under study - Intellectually or mental impaired subjects - Known hypersensitivity to class of drugs or the investigational product - Drug abuse - Known peripheral neuropathies - Diabetes mellitus - Chronic alcohol consumption - Congestive heart disease - Participants of other studies during study period and 30 days prior to study begin - Smoker - Abnormal electrocardiogram - Any regular concomitant medication |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich, Institut of Anaesthesiology | Zurich | ZH |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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