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

NCT01681966 | Completed Phase 2

• 1 other identifier: LNP-IL102
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative Pain intensity

  72 hours

Other Outcomes (2)

• Use of rescue medication

  72 hours

• Maximum plasma concentration (Cmax)

  72 hrs

Study Arms (1)

Application of PRF110- oily solution

EXPERIMENTAL

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

Drug: PRF110- oily solution (Ropivacaine)

Interventions

PRF110- oily solution (Ropivacaine) DRUG

Post operative application of PRF110-oily solution (Ropivacaine)

Also known as: Ropivacaine oily solution

Application of PRF110- oily solution

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• PainReform LTD: lead

Study Sites (3)

Western Galil Medical Center

Nahariya, 2210001, Israel

Location

Assaf Harofeh Medical Center

Rishon LeZiyyon, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Moaad Farraj, Dr.

  Galilee Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 10, 2012
• Study Start: September 1, 2012
• Primary Completion: May 4, 2016
• Study Completion: May 4, 2016
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

IL (3)