This phase IIa (proof of concept) study will be conducted as a multi-centre study within the European Union (EU). It will be conducted to a randomised, single blind, placebo- controlled, parallel group design with a positive control arm to evaluate the analgesic efficacy of pre-emptive doses of GW842166 following dental surgery (3rd molar tooth extraction). GW842166 will be administered as a single pre-operative oral dose in male and female subjects who will be randomised to take part in one of four possible treatment regimens. Pain assessments will be undertaken over a 10 hr period. Pharmacokinetic blood samples will be collected over a 48 hr period. Safety and tolerability will be evaluated by adverse event monitoring, cardiovascular assessments (ECG and vital signs) and clinical laboratory tests (haematology, clinical chemistry and urinalysis).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
112
GSK Investigational Site
Hamburg, Hamburg, Germany
GSK Investigational Site
Verona, Veneto, Italy
GSK Investigational Site
London, United Kingdom
Weighted mean of the pain intensity over the 10 hours post-surgery as measured by the VAS (Visual Analogue Scale)
Time frame: over the 10 hours post-surgery
-Weighted mean of the pain intensity over the 10 hours post-surgery,measured by the Verbal Rating Scale -VAS and VRS mean pain scores up to 10 hours post-surgery -Elapsed time from study drug administration to rescue analgesic request
Time frame: over the 10 hours post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.