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 - ND

• Conditions: inflammatory pain following dental extraction.; MedDRA version: 9.1Level: LLTClassification code 10062132Term: Tooth extraction

• Registration Number: EUCTR2005-004481-16-IT
• Lead Sponsor: GLAXOSMITHKLINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-29
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

-Healthy female or male subjects aged 18 to 50;

-women may be of child bearing potential or of non-child bearing potential; women of child bearing potential must use an effective method of contraception;

-subject is scheduled for outpatient surgical removal of at least one third molar mandibolar tooth under local anesthesia;

-subject agrees not to take analgesics other than protocol and provided by CRC 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 a history or presence of significant organ disease or mental illness;

-subject has been exposed to analgesics other than aspirin within 24 hours prior to the start of surgery;

-subject is unable to refrain from alcohol, psychoactive drugs, and sedative including sleeping preparations (eg.benzodizepines) within 24 hours prior to start of surgery and for the duration of their participation in the study;

-subject with a known allergy to or judged by an investigator not to be a suitable candidate for ibuprofen or co-codamol therapy based on medical history;

-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 grater than 14 units per week or an average daily intake of greater than two units for females.

Study & Design

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