Dose Response and Efficacy of GW842166 in Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

November 5, 2007

Last Updated Date

June 12, 2008

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00554762 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

• 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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dose Response and Efficacy of GW842166 in Pain

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: GW842166X

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

March 2008

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00554762

Responsible Party

Study ID Numbers ^ICMJE

CBA110877

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MRCP, FFPM

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP