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

NCT00883194 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-11-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PRF-108

Ropivacaine

DRUG

Placebo

PRF-108 Placebo

DRUG

Ropivacaine

Solution

DRUG

PRF-110

Sponsors & Collaborators

  • PainReform LTD

    lead INDUSTRY

Principal Investigators

  • Michael Naveh · PainReform LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00883194 on ClinicalTrials.gov