Dose Response and Efficacy of GW842166 in Pain - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: GW842166X	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

• 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 ]

Enrollment:	0
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554762

Locations


United Kingdom
	GSK Clinical Clinical Trials Call Center
	Cambridge, United Kingdom, CB2 2GG

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MRCP, FFPM	GlaxoSmithKline

More Information

Study ID Numbers:	CBA110877
First Received:	November 5, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00554762
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

GW842166,

Single,

dose,

repeat dose,

heat pain,

mechanical pain,

pharmacodynamics,

dose response,

efficacy

Study placed in the following topic categories:

Pain

Healthy

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00554762