NCT00883194

A Safety and Effectiveness Pilot Study of PRF-108 and PRF-110 in Healthy Volunteers

A Single-center, Randomized, Placebo-controlled, Double-blind, Single-dose, Efficacy of PRF-108 4% and PRF-110 4% Versus Ropivacaine Solution 0.5% in an Experimental Pain Model

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: PainReform LTD · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours.

Detailed description

This is a clinical study testing PRF-108 and PRF-110 (a new extended release 4% gel formulations of ropivacaine) in an experimentally induced pain model in healthy volunteers. PRF-108 and PRF-110 are designed to deliver slow release of ropivacaine over 72 hours. The purpose of this study is to investigate the safety (side effects if any occurs) associated with the single administration of PRF-108 or PRF-110 and evaluate their analgesic effect in an experimentally induced pain model compared with ropivacaine Solution 0.5% and Vehicle Gel.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	PRF-108	Ropivacaine
DRUG	Placebo	PRF-108 Placebo
DRUG	Ropivacaine	Solution
DRUG	PRF-110

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2009-04-17
• Last updated: 2020-11-16

Locations

1 site across 1 country: Israel