Completed

A Single-dose, Open-Label, Multi-center Study to Assess the Safety and Preliminary Efficacy of PRF 110 (Formerly LNP) in Open Herniorrhaphy Surgery

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What is being tested

PRF110- oily solution (Ropivacaine)

Drug
Who is being recruted

Neurologic Manifestations+4

+ Pain

+ Pathologic Processes

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorPainReform LTD
Last updated: November 16, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

LNP is new extended release (ER) 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 and hospital stays may be shortened. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the PK profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.

NCT01681966
Principal SponsorPainReform LTD
Last updated: November 16, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain, Postoperative

Criteria

5 inclusion criteria required to participate
Male subjects between 18-70 years of age who are scheduled to undergo open one sided herniorrhaphy surgery
Subject must be capable of reading, comprehending, and signing the informed consent form
Subjects are in good physical health (other than the need for the surgical procedure) as judged by physical and laboratory examinations and have a negative urine based screen for drugs of abuse
Subjects have a BMI of less than 30 kg/m2
Show More Criteria
14 exclusion criteria prevent from participating
Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol
Subjects that have a history of uncontrolled hypertension
Subjects who are members of the study site staff directly involved with the study or a relative of the Sponsor or other personnel involved with the study
Subjects who have donated blood within 3 months prior to the start of the study
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Post operative application of new extended release PRF110- oily solution (Ropivacaine)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Western Galil Medical Center

Nahariya, IsraelOpen Western Galil Medical Center in Google Maps

Assaf Harofeh Medical Center

Rishon LeZiyyon, Israel

Sourasky Medical Center

Tel Aviv, Israel
Completed3 Study Centers