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Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

NCT00913627 ↗

Phase 2 Completed 196 enrolled Pfizer
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, \[roller compaction\] and \[wet granulation\] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.

Timeline

Start
2009-05-07
Primary completion
2009-08-01
Completion
2009-08-05

Outcome

Met primary endpoint

registry Placebo vs Ibuprofen IR/ER (Roller Compaction); p <0.001; Mean Difference (Final Values) 16.16 (95% CI 12.13 to 20.19) NCT00913627 ↗

registry Placebo vs Ibuprofen IR/ER (Wet Granulation); p <0.001; Mean Difference (Final Values) 17.00 (95% CI 13.02 to 20.99) NCT00913627 ↗

registry Placebo vs Ibuprofen IR/ER (Roller Compaction); p <0.001; Mean Difference (Final Values) 6.34 (95% CI 4.30 to 8.38) NCT00913627 ↗

registry Placebo vs Ibuprofen IR/ER (Wet Granulation); p <0.001; Mean Difference (Final Values) 7.06 (95% CI 5.05 to 9.08) NCT00913627 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule 600 mg —
Comparator Naproxen Small molecule 220 mg —

Indications

No indication recorded.