drugset / Trial / NCT00964431

Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

NCT00964431 ↗

Phase 2 Completed 203 enrolled Iroko Pharmaceuticals, LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start
2009-08
Primary completion
2009-12
Completion
2009-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Indomethacin Test (Upper Dose) vs Placebo; p <0.001; Mean Difference (Net) 9.545 (95% CI 5.816 to 13.275); ANCOVA NCT00964431 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Celecoxib Other / unclassified 400 mg —
Subject Indomethacin Small molecule 20 mg —
Subject Indomethacin Small molecule 40 mg —

Indications

No indication recorded.