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. - ND

• Conditions: inflammatory pain following dental extraction; MedDRA version: 8.1Level: LLTClassification code 10062132Term: Tooth extraction

• Registration Number: EUCTR2006-002691-18-IT
• Lead Sponsor: GLAXOSMITHKLINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

- Female or male subjects aged 18 to 50. - Body weight 61619; 50 kg and BMI within the range 19 - 29.9 kg/m2. - Women may be of non-child bearing potential or they may be of child-bearing potential. Women of child-bearing potential must use an effective method of contraception. - Subject is scheduled for outpatient surgical removal of up to four third molar teeth under local anaesthesia. - Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Subject has been exposed to analgesics within 48 hours prior to the start of surgery. - Subject is unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations e.g. benzodiazepines within 48 hours prior from the start of surgery and for 48hrs post dose. -Subject is judged by the investigator not to be a suitable candidate for ibuprofen or co-codamol therapy. - The subject had a history of drug or alcohol abuse, or had a positive pre-study urine drug / alcohol breath screen. Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units for males and intake greater than 14 units per week or an average daily intake of greater than two units for females. - The subject is currently participating or has participated in a clinical trial during the previous 6 months. - The subject is known to have Gilbert s disease, or has a serum bilirubin concentration more than 1.5 times the upper limit of normal.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified