NCT02784327

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery

A Single-Dose, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: PainReform LTD · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

PRF110 is new extended release oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The purpose of this study is to determine the safety and early efficacy of PRF110 in bunionectomy surgery, to measure the pharmacokinetic profile of PRF110 over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.

Detailed description

PRF110 is new extended release oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The formulation is designed to slowly release the ropivacaine over 36-72 hours. By providing local analgesia over a long time span, the need for systemic analgesics is expected to be reduced. The purpose of this study is to determine the safety and early efficacy of PRF110 in bunionectomy surgery, to measure the pharmacokinetic profile of PRF110 over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	PRF110

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2016-05-27
• Last updated: 2016-05-27

Locations

2 sites across 1 country: Israel