drugset / Trial / NCT00985439

Study of Diclofenac Capsules to Treat Dental Pain

NCT00985439 ↗

Phase 2 Completed 202 enrolled Iroko Pharmaceuticals, LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.

Timeline

Start
2009-09
Primary completion
2009-12
Completion
2009-12

Outcome

Met primary endpoint

registry Diclofenac Test (Upper Dose) vs Placebo; p <0.001; Mean Difference (Net) 11.407 (95% CI 6.195 to 16.619); ANCOVA NCT00985439 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 400 mg —
Subject Diclofenac Other / unclassified 18 mg —
Subject Diclofenac Other / unclassified 35 mg —

Indications

No indication recorded.