drugset
drugset / Trial / NCT04908748

Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain

NCT04908748 ↗

Phase 2 Completed 200 enrolled Teikoku Seiyaku Co., Ltd. CRM Biometrics GmbH · collabClinSearch · collabClinigen, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Objective of this study is: to determine efficacy and safety of a Esflurbiprofen Hydrogel Patch compared to placebo in patients with acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sports injuries. to demonstrate that the Esflurbiprofen Hydrogel Patch is superior to placebo, and that the patch has acceptable local tolerability.

Timeline

Start
2021-05-20
Primary completion
2021-11-09
Completion
2021-12-15

Outcome

Met primary endpoint

registry analysis (superiority test); Active Arm vs Control Drug; p < 0.0001; Least squares mean difference -29.1 (95% CI -32.2 to -26.0); ANCOVA NCT04908748 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Esflurbiprofen Small molecule 165 mg —

Indications

No indication recorded.