NCT01485185

Gabapentin and Donepezil Combination on Experimental Human Pain Models

Completed Phase 1 Last updated 12 June 2017

What this trial tests

Phase 1 trial testing Gabapentin lower dose in Pain, Neuropathic in 48 participants. Completed in 3 July 2012.

Timeline

11 October 2011

Primary endpoint
3 July 2012

3 July 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	48
Start date	11 October 2011
Primary completion	3 July 2012
Estimated completion	3 July 2012
Sites	1 location across United Kingdom

Drugs / interventions tested

• Gabapentin lower dose — full drug profile →
• Donepezil (DONEPEZIL) — full drug profile →
• Placebo (Dop)
• Placebo (Gaba)
• Gabapentin higher dose — full drug profile →

Conditions studied

• Pain, Neuropathic — all drugs for Pain, Neuropathic →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 55, male only, with Pain, Neuropathic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effect of a combination of gabapentin and donepezil in an experimental pain model in healthy volunteers: Results of a randomized controlled trial.
   Boyle Y, Fernando D, Kurz H, Miller SR, et al · · 2014 · cited 21× · PMID 25218827 · DOI 10.1016/j.pain.2014.09.003
2. Application of sample size re-estimation in clinical trials: A systematic review.
   Mano H, Tanaka Y, Orihara S, Moriya J. · · 2023 · cited 4× · PMID 37842317 · DOI 10.1016/j.conctc.2023.101210