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A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery

NCT01681966 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-11-16

No results posted yet for this study

Summary

LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.

Conditions

  • Post Operative Pain

Interventions

DRUG

PRF110- oily solution (Ropivacaine)

Post operative application of PRF110-oily solution (Ropivacaine)

Sponsors & Collaborators

  • PainReform LTD

    lead INDUSTRY

Principal Investigators

  • Moaad Farraj, Dr. · Galilee Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-05-04
Completion
2016-05-04

Countries

  • Israel

Study Locations

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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 NCT01681966 on ClinicalTrials.gov