drugset / Trial / NCT05773846

A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain

NCT05773846

RandomizedParallel-groupQuadruple-blindTreatment

Summary

PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia. The pharmacokinetic profile for PRF-110 suggests that its effect could last up to 72 hours. This is A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

Timeline

Start
2023-03-13
Primary completion
2024-07-30
Completion
2024-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified 0.5 % Other
Subject Ropivacaine Other / unclassified 3.6 % Other

Indications