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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00444769 |
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).
Condition | Intervention | Phase |
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Pain |
Drug: GW842166 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Centre, Randomised, Single-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy of Single Pre-Emptive Doses of GW842166X, a Non-Cannabinoid CB2 Receptor Agonist, on Pain Following Third Molar Tooth Extraction. |
Enrollment: | 112 |
Study Start Date: | October 2006 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Females of non-child bearing potential are defined as:
Exclusion Criteria:
Germany | |
GSK Investigational Site | |
Hamburg, Germany, 22769 | |
Italy, Veneto | |
GSK Investigational Site | |
Verona, Veneto, Italy, 37134 | |
United Kingdom | |
GSK Investigational Site | |
London, United Kingdom, WC1X 8LD |
Study Director: | GSK Clinical Trials, PhD. | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CBA106809 |
Study First Received: | March 6, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00444769 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy : Ethics Committee of the Verona Hospital Board |
analgesia post-operative pain GW842166 non-cannabinoid agonist third molar tooth extraction |
Toothache Pain Pain, Postoperative |