A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery

NCT02784327 | Unknown Phase 2

• 1 other identifier: PRF110-102
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

PRF110 is new extended release oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The purpose of this study is to determine the safety and early efficacy of PRF110 in bunionectomy surgery, to measure the pharmacokinetic profile of PRF110 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

  All adverse events (AE) reported by the subjects will be recorded throughout the trial period

  10 days

Secondary Outcomes (4)

• Time to first rescue medication

  72 hours

• Total amount of rescue medication used during the study

  10 days

• Pain intensity recorded at rest

  72 hours

• Subject global assessment of PRF110

  72 hours

Other Outcomes (1)

• PRF110 plasma concentrations

  72 hours

Study Arms (1)

PRF110- oily solution

EXPERIMENTAL

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

Drug: PRF110

Interventions

PRF110 DRUG

Also known as: Ropivacaine oily solution

PRF110- oily solution

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent prior to any study procedures;
• Able to communicate clearly with the Investigators and study staff;
• Males and females aged between 18 - 85 years of age;
• Scheduled for elective primary unilateral first metatarsal bunionectomy surgery (osteotomy and internal fixation) with no collateral procedures;
• Females must be physically incapable of childbearing potential (postmenopausal for more than at least 2 years or surgically sterile) or practicing an acceptable method of contraception (hormonal, barrier with spermicide, intrauterine device, vasectomized partner, or abstinence). Subjects using hormonal birth control must have received at least 1 cycle of treatment prior to study drug administration. At Baseline, all females of childbearing potential must have a negative pregnancy test and not be breast feeding;
• Negative urine drug screen for drugs of abuse at Screening and on Day 1 prior to surgery; a positive drug screen result may be permitted if the subject has been on a stable dose of an allowed medication for \>30 days (antipsychotics, antiepileptics, sedatives, hypnotics, antianxiety agents, or antidepressants);
• American Society of Anesthesiologists (ASA) risk class of I to II;
• Body Mass Index ≤32.

You may not qualify if:

• Has known allergies to an opioid, unless has subsequently tolerated other opioids and, in the opinion of the Investigator, could tolerate a rescue drug containing fentanyl;
• Has a known or suspected allergy to paracetamol, ibuprofen or dipyrone;
• Has a known or suspected allergy to any local anesthetic;
• Has atrial fibrillation/flutter, an inserted pacemaker, or complete left bundle branch block (LBBB) on ECG; or myocardial infarction within 6 months prior to surgery;
• Has a clinically significant abnormal ECG at screening;
• Has a known or suspected history of diagnosed alcohol, opiate or other substance abuse within 12 months prior to screening;
• Is unable to refrain from alcohol consumption for a period beginning 24 hours prior to surgery through the end of the 72 hour evaluation period;
• Has taken any analgesic within 12 hours or any aspirin-containing product within 7 days of the Baseline assessments;
• Has taken any opioid analgesics or used systemic steroids within 4 days of surgery;
• Has been using opiates or any non-steroidal anti-inflammatory drug chronically (more than 10 consecutive days) anytime over the past 3 months;
• Has used antipsychotics, antiepileptics, sedatives, hypnotics, antianxiety agents or antidepressants for \< 30 days prior to surgery or had a dose change within the previous 30 days;
• Has taken any prescription or over-the-counter medication within 4 days prior to surgery that, in the opinion of the Investigator, could potentially confound the analgesic response;
• Has taken herbal agents or nutraceuticals during any of the 7 days prior to surgery that, in the opinion of the Investigator, could potentially confound the analgesic response;
• Has any clinically significant condition or a significant laboratory abnormality that would, in the opinion of the Investigator, preclude study participation;
• Unable or unwilling, in the opinion of the Investigator to comply with the requirements of the protocol;

Sponsors & Collaborators

• PainReform LTD: lead

Study Sites (2)

The Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Shai Efrati, Dr.

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

• Natan Bruck, Dr.

  The Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigal Aviel, Dr.

CONTACT

+972-9-9601911; saviel@painreform.com

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: May 24, 2016
• First Posted: May 27, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

IL (2)