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GSK1014802 low dose
Effect of GSK1014802 on Electrical Hyperalgesia and Threshold Tracking in Healthy Subjects
Ensayo de BIOGEN INC. en Dolor Neuropatico · Dolor Neuropatico.
Más ensayos de: Dolor neuropático.
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 16
- Fin del objetivo primario
- nov 2009
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jul 2009.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «During treatment session 3, a subject had a pattern of AEs of severe intensity, suggestive of brainstem toxicity/encephalopathy during lidocaine/saline infusion».
Qué mide
Determinar el efecto de dosis orales unicas de GSK1014802 sobre el area de eritema evocada por estimulacion electrica cutanea. (16 semanas)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study is being conducted to assess the effects of GSK1014802 and a positive control, lidocaine, on tests of peripheral nerve excitability. This will be a double blind, placebo controlled, 4-period cross over study. Approximately 20 subjects will be randomised to one of two doses of a GSK1014802, lidocaine and placebo with at least 2 weeks between sessions. A follow-up will occur 7-15 days after the last dose. During treatment session 3 on the 6th October 2009, one subject had a pattern of AEs of severe intensity, suggestive of brain stem toxicity / encephalopathy during the lidocaine/saline infusion period. Although recognised in the literature when lidocaine was used in patients for treatment of pain, these AEs were unusual in studies in healthy subjects. The study was suspended to allow re-evaluation of the risk:benefit balance of lidocaine/saline infusion in healthy subjects in this study. It was decided that continuation of the use of lidocaine (positive control) would risk the safety of subjects. Continuation without the positive control was not possible as it would compromise the scientific integrity of the design.
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Ficha completa en ClinicalTrials.gov (NCT00964288), actualizada en oct 2017.