drugset / Trial / NCT01485185

Gabapentin and Donepezil Combination on Experimental Human Pain Models

NCT01485185

Phase 1 Completed 48 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindBasic science

Summary

This study will compare the effects of gabapentin alone, and gabapentin + donepezil given together in two types of experimental electrical pain tests in up to 48 healthy male subjects (after 24 recruited in the first cohort an interim analysis will be performed). The study is a randomized, double blind, placebo controlled, 3 was cross-over design study with incomplete block design and 4 treatment options. Placebo, gabapentin alone (lower dose and higher dose) or gabapentin (lower dose) with donepezil.

Timeline

Start
2011-10-11
Primary completion
2012-07-03
Completion
2012-07-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule 5 mg Oral
Subject Gabapentin Small molecule 900 mg Oral
Subject Gabapentin Small molecule 1800 mg Oral

Indications