Post Operative PainPhase 2NCT01681966
A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery
A Phase 2 study testing PRF110- oily solution (Ropivacaine) in people with Post Operative Pain, run by PainReform LTD at 3 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- PRF110- oily solution (Ropivacaine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesIsrael
- Study dates
- Sep 2012to 4 May 2016
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Western Galil Medical Center
Nahariya, 2210001
Assaf Harofeh Medical Center
Rishon LeZiyyon
Sourasky Medical Center
Tel Aviv
About this study
Official title: A Single-dose, Open-Label, Multi-center Study to Assess the Safety and Preliminary Efficacy of PRF 110 (Formerly LNP) in Open Herniorrhaphy Surgery
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.
Read the detailed description
LNP is new extended release (ER) 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 and hospital stays may be shortened. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the PK profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.
- Conditions
- Post Operative Pain
- Being tested
- PRF110- oily solution (Ropivacaine)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRF110- oily solution (Ropivacaine)Drug
Also called Ropivacaine oily solution
Post operative application of PRF110-oily solution (Ropivacaine)
| Study group | Role | What they receive |
|---|---|---|
| Application of PRF110- oily solution | Experimental | Post operative application of new extended release PRF110- oily solution (Ropivacaine) Receives: Drug: PRF110- oily solution (Ropivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (safety and tolerability).
All adverse events (AE) reported by the subjects will be recorded throughout the trial period
Measured: 72 hours
Secondary outcomes (1)
Post-operative Pain intensity
Pain on a scale of 0-10 assessed at 0,1,2,4,8,12,24,36,48,60,72hrs post operation will be used to evaluate pain intensity
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 posted10 Sep 2012 (estimated)
- Study startSep 2012
- Primary completion4 May 2016
- Study completion4 May 2016
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 (actual)
Sponsor and investigators
- Lead sponsor
- PainReform LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moaad Farraj, Dr., Principal investigator, Galilee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681966
- Sponsor's protocol ID
- LNP-IL102
- Status last verified
- Nov 2020
- First submitted
- 5 Sep 2012
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-Label, Multi-center Study to Assess the Safety and Preliminary Efficacy of PRF 110 (Formerly LNP) in Open Herniorrhaphy Surgery
- ClinicalTrials.gov ID
- NCT01681966
- Acronym / sponsor ID
- LNP-IL102
- Conditions
- Post Operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PainReform LTDIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- 4 May 2016 (actual)
- Study completion
- 4 May 2016 (actual)
- First posted
- 10 Sep 2012 (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.
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.
Detailed description
LNP is new extended release (ER) 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 and hospital stays may be shortened. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the PK profile of LNP 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 |
|---|---|---|
| Application of PRF110- oily solution | Experimental | Drug: PRF110- oily solution (Ropivacaine)Post operative application of new extended release PRF110- oily solution (Ropivacaine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
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 |
|---|---|---|
| PRF110- oily solution (Ropivacaine)Also: Ropivacaine oily solutionPost operative application of PRF110-oily solution (Ropivacaine) | Drug | Application of PRF110- oily solution |
Primary outcome
Incidence of treatment emergent adverse events (safety and tolerability).
Time frame: 72 hours
All adverse events (AE) reported by the subjects will be recorded throughout the trial period
1 secondary outcome
Post-operative Pain intensity
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
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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.
Moaad Farraj, Dr. principal investigator
Galilee Medical Center
3 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- oily solution (Ropivacaine) in people with Post Operative Pain, run by PainReform LTD at 3 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (safety and tolerability). (time frame: 72 hours). 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 16 Nov 2020.