drugset / Trial / NCT05773846
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropivacaine | Other / unclassified | 0.5 % | Other |
| Subject | Ropivacaine | Other / unclassified | 3.6 % | Other |