drugset / Trial / NCT00967707

Population Pharmacokinetic-pharmacodynamic (PK-PD) Modeling of Co-administered Gabapentin in Neuropathic Pain

NCT00967707

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to develop a pharmacokinetic (PK) and a pharmacokinetic-pharmacodynamic (PK-PD) model for gabapentin in patients with neuropathic pain. The secondary objectives are to investigate whether adjuvant therapy of venlafaxine or donepezil contributes to 1) improved analgesic efficacy and 2) improved health-related quality of life (assessed by the SF-36 questionnaire) in neuropathic pain patients treated with gabapentin.

Timeline

Start
2009-08
Primary completion
2011-04
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Donepezil Small molecule 5 mg
Comparator Gabapentin Small molecule 800 mg
Comparator Venlafaxine Small molecule 75 mg

Indications