Clincosm LogoSign in Get a demo

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

Sponsor
PainReform LTD (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02784327
Collaborator
(none)
15
Enrollment
2
Locations
1
Arm
10
Duration (Months)
7.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRF110 is new extended release 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. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-Dose, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2017
Anticipated Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRF110- oily solution

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

Drug: PRF110
Other Names:
  • Ropivacaine oily solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of treatment emergent adverse events [10 days]

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

    Secondary Outcome Measures

    1. Time to first rescue medication [72 hours]

      Time to first rescue medication

    2. Total amount of rescue medication used during the study [10 days]

      Total amount of rescue medication used during the study

    3. Pain intensity recorded at rest [72 hours]

      Pain intensity which will be recorded at rest at Hours 1, 2, 4, 6, 8, 10, 12, 18 (optional) 24, 28, 32, 36, 48, 52, 56, 60 and 72.

    4. Subject global assessment of PRF110 [72 hours]

      Subject global assessment which will be recorded at Hours 24, 48 and 72.

    Other Outcome Measures

    1. PRF110 plasma concentrations [72 hours]

      Samples will be collected at designated times up to 72hrs post drug application

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Able to provide written informed consent prior to any study procedures;

    2. Able to communicate clearly with the Investigators and study staff;

    3. Males and females aged between 18 - 85 years of age;

    4. Scheduled for elective primary unilateral first metatarsal bunionectomy surgery (osteotomy and internal fixation) with no collateral procedures;

    5. 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;

    6. 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);

    7. American Society of Anesthesiologists (ASA) risk class of I to II;

    8. Body Mass Index ≤32.

    Exclusion Criteria:

    1. 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;

    2. Has a known or suspected allergy to paracetamol, ibuprofen or dipyrone;

    3. Has a known or suspected allergy to any local anesthetic;

    4. 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;

    5. Has a clinically significant abnormal ECG at screening;

    6. Has a known or suspected history of diagnosed alcohol, opiate or other substance abuse within 12 months prior to screening;

    7. 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;

    8. Has taken any analgesic within 12 hours or any aspirin-containing product within 7 days of the Baseline assessments;

    9. Has taken any opioid analgesics or used systemic steroids within 4 days of surgery;

    10. Has been using opiates or any non-steroidal anti-inflammatory drug chronically (more than 10 consecutive days) anytime over the past 3 months;

    11. 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;

    12. 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;

    13. 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;

    14. Has any clinically significant condition or a significant laboratory abnormality that would, in the opinion of the Investigator, preclude study participation;

    15. Unable or unwilling, in the opinion of the Investigator to comply with the requirements of the protocol;

    16. Has received another investigational drug within 30 days of scheduled surgery;

    17. Has donated blood within three months prior to start of the study;

    18. Employees of the Investigator and study site or the sponsor, as well as family members of the employees or the investigator or the sponsor.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Chaim Sheba Medical Center Ramat Gan Israel 52621
    2 Assaf Harofeh Medical Center Zerifin Israel 70300

    Sponsors and Collaborators

    • PainReform LTD

    Investigators

    • Principal Investigator: Shai Efrati, Dr., Assaf-Harofeh Medical Center
    • Principal Investigator: Natan Bruck, Dr., The Chaim Sheba Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PainReform LTD
    ClinicalTrials.gov Identifier:
    NCT02784327
    Other Study ID Numbers:
    • PRF110-102
    First Posted:
    May 27, 2016
    Last Update Posted:
    May 27, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Pain, Postoperative
    Ropivacaine

    Study Results

    No Results Posted as of May 27, 2016