Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy

Phase 4 Completed 401 enrolled GlaxoSmithKline

RandomizedParallel-groupDouble-blindTreatment

Summary

GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 18 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).

Timeline

Start: 2009-11
Primary completion: 2010-03
Completion: 2010-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Paracetamol Caplet 1000mg vs Placebo Caplet; p <0.0001; Adjusted Mean DIfference 11.33 (95% CI 8.66 to 14.00); ANCOVA NCT01075243 ↗

Publications

Yue Y, Collaku A, Brown J, Buchanan WL, Reed K, Cooper SA, Otto J. Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. Clin Ther. 2013 Sep;35(9):1306-20. doi: 10.1016/j.clinthera.2013.07.422. Epub 2013 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	650 mg	—
Subject	Acetaminophen	Small molecule	1000 mg	—

Indications

No indication recorded.