Post Operative PainPhase 2NCT02784327
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery
A Phase 2 study testing PRF110 in people with Post Operative Pain, run by PainReform LTD at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- PRF110
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesIsrael
- Study dates
- Aug 2016to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
The Chaim Sheba Medical Center
Ramat Gan, 52621
Natan Bruck, Dr., +972-3-530-3030
Assaf Harofeh Medical Center
Tsrifin, 70300
Shai Efrati, Dr., +972-8-977-9393/5
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Operative Pain
- Being tested
- PRF110
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF110Drug
Also called Ropivacaine oily solution
| Study group | Role | What they receive |
|---|---|---|
| PRF110- oily solution | Experimental | Post-operative application of new extended release PRF110- oily solution (Ropivacaine) Receives: Drug: PRF110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
All adverse events (AE) reported by the subjects will be recorded throughout the trial period
Measured: 10 days
Secondary outcomes (4)
Time to first rescue medication
Time to first rescue medication
Measured: 72 hours
Total amount of rescue medication used during the study
Total amount of rescue medication used during the study
Measured: 10 days
Pain intensity recorded at rest
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.
Measured: 72 hours
Subject global assessment of PRF110
Subject global assessment which will be recorded at Hours 24, 48 and 72.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PainReform LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shai Efrati, Dr., Principal investigator, Assaf-Harofeh Medical CenterNatan Bruck, Dr., Principal investigator, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784327
- Sponsor's protocol ID
- PRF110-102
- Status last verified
- May 2016
- First submitted
- 24 May 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery
- ClinicalTrials.gov ID
- NCT02784327
- Acronym / sponsor ID
- PRF110-102
- Conditions
- Post Operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- PainReform LTDIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRF110- oily solution | Experimental | Drug: PRF110Post-operative application of new extended release PRF110- oily solution (Ropivacaine) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRF110Also: Ropivacaine oily solution | Drug | PRF110- oily solution |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 10 days
All adverse events (AE) reported by the subjects will be recorded throughout the trial period
4 secondary outcomes
Time to first rescue medication
Time frame: 72 hours
Total amount of rescue medication used during the study
Time frame: 10 days
Pain intensity recorded at rest
Time frame: 72 hours
Subject global assessment of PRF110
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shai Efrati, Dr. principal investigator
Assaf-Harofeh Medical Center
Natan Bruck, Dr. principal investigator
The Chaim Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRF110 in people with Post Operative Pain, run by PainReform LTD at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigal Aviel, Dr. (+972-9-9601911, saviel@painreform.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2016.