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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00281684 |
This clinical trial is a multi centre, randomised, single-blind, parallel group, placebo-controlled, single oral dose study with a positive control arm. Patients previously scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon completion of surgery, e.g. prior to established pain, patients will be randomised to treatment (SB-706598, placebo or co-codamol) and dosed with the study medication
Condition | Intervention | Phase |
---|---|---|
Dental Pain |
Drug: SB-705498 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Centre, Randomised, Single Blind, Placebo Controlled, Parallel Group Study to Examine the Effect of Single Doses of SB-705498, a TRPV1 Receptor Antagonist, on Pain Following Third Molar Tooth Extraction |
Enrollment: | 137 |
Study Start Date: | December 2005 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Italy, Veneto | |
GSK Investigational Site | |
Verona, Veneto, Italy, 37134 | |
Korea, Republic of | |
GSK Investigational Site | |
Seoul, Korea, Republic of, 110-768 | |
United Kingdom | |
GSK Investigational Site | |
Manchester, United Kingdom, M13 9WL | |
GSK Investigational Site | |
Leeds, United Kingdom, LS2 9NG | |
United Kingdom, Surrey | |
GSK Investigational Site | |
Croydon, Surrey, United Kingdom, CR7 7YE |
Study Director: | GSK Clinical Trials, B.Sc. | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | VRA105345 |
Study First Received: | January 23, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00281684 |
Health Authority: | United Kingdom: Research Ethics Committee |
VR1 TRPV1 Inflammation |
Dental Pain Acute Pain Vanilloid |
Signs and Symptoms Tooth Diseases Facies Facial Pain |
Toothache Pain Stomatognathic Diseases Inflammation |