Dose Response and Efficacy of GW842166 in Pain - Tabular View

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Dose Response and Efficacy of GW842166 in Pain

This study has been terminated.

Study NCT00554762. Last updated on June 12, 2008. Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Dose Response and Efficacy of GW842166 in Pain

Official Title ^†

A Phase I, Placebo Controlled, Randomised, Double Blind Two-Way Crossover Study to Investigate the Dose Response and Efficacy of Single and Repeat Doses of GW842166 in Healthy Volunteers Using Pharmacodynamic Pain Assessments.

Brief Summary

The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.

Detailed Description

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Primary Outcome Measure ^†

• Heat pain threshold at 5 hours post dose [ Time Frame: 5 Hours ]

Secondary Outcome Measure ^†

• Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose. [ Time Frame: 5 Hours ]

Condition ^†

Healthy Volunteers

Intervention ^†

Drug: GW842166X

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

November 2007

Completion Date

March 2008

Eligibility Criteria ^†

Inclusion Criteria:

Healthy male or female subjects aged 18 to 50 years inclusive
Body Weight >50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
Women who are not of child bearing potential

Exclusion Criteria:

The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00554762

Organization ID

CBA110877

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MRCP, FFPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2008

First Received Date ^†

November 5, 2007

Last Updated Date

June 12, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.