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Dose Response and Efficacy of GW842166 in Pain
This study has been terminated.
( cancelled before enrollment )
Study NCT00554762   Information provided by GlaxoSmithKline
First Received: November 5, 2007   Last Updated: June 12, 2008   History of Changes

November 5, 2007
June 12, 2008
November 2007
March 2008   (final data collection date for primary outcome measure)
• Heat pain threshold at 5 hours post dose [ Time Frame: 5 Hours ]
Same as current
Complete list of historical versions of study NCT00554762 on ClinicalTrials.gov Archive Site
• 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 ]
Same as current
 
Dose Response and Efficacy of GW842166 in Pain
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.

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.

 
Phase I
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Healthy Volunteers
Drug: GW842166X
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
0
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00554762
 
CBA110877
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MRCP, FFPM GlaxoSmithKline
GlaxoSmithKline
June 2008

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