At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo- and Active-controlled Trial to Investigate the Single-dose Efficacy, Safety, and Pharmacokinetics of 250 and 1000 mg JNJ-10450232 in Postoperative Dental Pain
In Brief
A Phase 2 clinical trial evaluating JNJ-10450232 / Not yet marketed and acetaminophen / Tylenol for Pain. Completed, enrolled 269 participants across 1 site.
Detailed Summary
To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.
Study Details
Timeline
Interventions
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.