Post-operative Dental Pain Study Comparing Analgesic Efficacy

Summary

GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . 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 16 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).

Timeline

Start

2009-10

Primary completion

2010-03

Completion

2010-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Paracetamol Caplet 1000 mg vs Placebo Caplet; p <0.0001; Adjusted Mean Difference 7.25 (95% CI 4.04 to 10.45); ANCOVA NCT01082081 ↗

registry analysis (superiority or other test); Paracetamol Caplet 1000 mg vs Paracetamol Caplet 500 mg; p = 0.0004; Adjusted Mean Difference 4.77 (95% CI 2.15 to 7.39); ANCOVA NCT01082081 ↗

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	500 mg	—
Subject	Acetaminophen	Small molecule	1000 mg	—

Indications

No indication recorded.