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

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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: PRF110- oily solution (Ropivacaine)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel, 2210001
    • Western Galil Medical Center
  • Rishon LeZion, Israel
    • Assaf Harofeh Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male subjects between 18-70 years of age who are scheduled to undergo open one sided herniorrhaphy surgery;
• Subjects have a BMI of less than 30 kg/m2;
• 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 must agree to refrain from ingesting any analgesic medication for at least 2 days (or 5 half-lives of the analgesic drug) prior to surgery; refrain from alcohol and excessive caffeine intake on the day of surgery and during 72 hours after surgery;
• Subject must be capable of reading, comprehending, and signing the informed consent form;

Exclusion Criteria:

• Subjects with a history of melena or any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders;
• Subjects with a history of any type of cancer within 5 years of surgery;
• Subjects with any history of alcohol or substance abuse;
• Subjects that have a history of uncontrolled hypertension;
• Subjects with a known hypersensitivity to any local anesthetic drug;
• Subjects with a hemoglobin concentration of less than 10.0 g/dL;
• Subjects with any clinically significant abnormal lab result (as judged by the Principal Investigator);
• Subjects with atrial fibrillation/flutter, an inserted pacemaker, or complete left bundle branch block (LBBB) on ECG; or myocardial infarction within 6 months prior to surgery;
• Subjects with a clinically significant abnormal ECG at screening;
• Subjects with any condition or history judged by the Investigator to place the subject at increased risk;
• Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
• Subjects who have used an investigational drug within 30 days prior to entering the study;
• Subjects who have donated blood within 3 months prior to the start of the study;
• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Application of PRF110- oily solution; Post operative application of new extended release PRF110- oily solution (Ropivacaine)	Drug: PRF110- oily solution (Ropivacaine); Post operative application of PRF110-oily solution (Ropivacaine); Other Names: Ropivacaine oily solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events (safety and tolerability).	All adverse events (AE) reported by the subjects will be recorded throughout the trial period	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain intensity	Pain on a scale of 0-10 assessed at 0,1,2,4,8,12,24,36,48,60,72hrs post operation will be used to evaluate pain intensity	72 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of rescue medication	Overall use of rescue medication post operation	72 hours
Maximum plasma concentration (Cmax)	Samples will be collected at designated times up to 72hrs post drug application	72 hrs

Collaborators and Investigators

• Sponsor: PainReform LTD
• Investigators: Principal Investigator: Moaad Farraj, Dr., Galilee Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): May 4, 2016
• Study Completion (ACTUAL): May 4, 2016

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (ESTIMATE): September 10, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: LNP-IL102