- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02784327
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery
May 24, 2016 updated by: PainReform LTD
A Single-Dose, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sigal Aviel, Dr.
- Phone Number: +972-9-9601911
- Email: saviel@painreform.com
Study Locations
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Ramat Gan, Israel, 52621
- The Chaim Sheba Medical Center
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Contact:
- Natan Bruck, Dr.
- Phone Number: +972-3-530-3030
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Zerifin, Israel, 70300
- Assaf Harofeh Medical Center
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Contact:
- Shai Efrati, Dr.
- Phone Number: +972-8-977-9393/5
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Has received another investigational drug within 30 days of scheduled surgery;
- Has donated blood within three months prior to start of the study;
- Employees of the Investigator and study site or the sponsor, as well as family members of the employees or the investigator or the sponsor.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: PRF110- oily solution
Post-operative application of new extended release PRF110- oily solution (Ropivacaine)
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment emergent adverse events
Time Frame: 10 days
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All adverse events (AE) reported by the subjects will be recorded throughout the trial period
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10 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first rescue medication
Time Frame: 72 hours
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Time to first rescue medication
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72 hours
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Total amount of rescue medication used during the study
Time Frame: 10 days
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Total amount of rescue medication used during the study
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10 days
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Pain intensity recorded at rest
Time Frame: 72 hours
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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.
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72 hours
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Subject global assessment of PRF110
Time Frame: 72 hours
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Subject global assessment which will be recorded at Hours 24, 48 and 72.
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72 hours
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PRF110 plasma concentrations
Time Frame: 72 hours
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Samples will be collected at designated times up to 72hrs post drug application
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72 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shai Efrati, Dr., Assaf-Harofeh Medical Center
- Principal Investigator: Natan Bruck, Dr., The Chaim Sheba Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
May 24, 2016
First Submitted That Met QC Criteria
May 24, 2016
First Posted (Estimate)
May 27, 2016
Study Record Updates
Last Update Posted (Estimate)
May 27, 2016
Last Update Submitted That Met QC Criteria
May 24, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRF110-102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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