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Gabapentin and Donepezil Combination on Experimental Human Pain Models

NCT01485185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-06-12

No results posted yet for this study

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.

Conditions

  • Pain, Neuropathic

Interventions

DRUG

Gabapentin lower dose

Repeat, oral dose

DRUG

Donepezil

Repeat, oral dose

OTHER

Placebo (Dop)

Placebo to donepezil, Repeat, oral dose

OTHER

Placebo (Gaba)

Placebo to gabapentin, Repeat, oral dose

DRUG

Gabapentin higher dose

Repeat, oral dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01485185 on ClinicalTrials.gov