Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444769
Status:
COMPLETED
Last Update Posted:
2009-05-18
First Post:
2007-03-06
Brief Title:
Dental Pain 3rd Molar Tooth Extraction GW842166
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None