Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

Summary

The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.

Timeline

Start

2010-11-22

Primary completion

2011-03-31

Completion

2011-03-31

Outcome

Met primary endpoint

registry MEAN Ibuprofen: 41.5 (Standard Deviation 21.0) units on a scale NCT01266161 ↗

registry analysis (superiority test); Placebo vs Ibuprofen; p <0.001; Mean Difference (Final Values) 23.76 (95% CI 16.45 to 31.07); ANOVA NCT01266161 ↗

registry MEAN Ibuprofen: 18.4 (Standard Deviation 12.1) units on a scale NCT01266161 ↗

registry analysis (superiority test); Placebo vs Ibuprofen; p <0.001; Mean Difference (Final Values) 8.42 (95% CI 4.13 to 12.71); ANOVA NCT01266161 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibuprofen	Small molecule	600 mg	—

Indications

No indication recorded.