NCT00281684

SB-705498 Dental Pain Study After Tooth Extraction

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Toothache

Interventions

Type	Name	Description
DRUG	SB705498 400 mg	SB705498 400 mg
DRUG	SB705498 1000 mg	SB705498 1000 mg
DRUG	Placebo	Placebo
DRUG	Co-Codamol	Co-Codamol

Timeline

• Start date: 2005-12-07
• Primary completion: 2007-10-03
• Completion: 2007-10-03
• First posted: 2006-01-25
• Last updated: 2019-01-28
• Results posted: 2019-01-28

Locations

5 sites across 3 countries: Italy, South Korea, United Kingdom