Back to resultsA Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
PRF110- oily solution (Ropivacaine)
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- 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;
Sites / Locations
- Western Galil Medical Center
- Assaf Harofeh Medical Center
- Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Application of PRF110- oily solution
Arm Description
Post operative application of new extended release PRF110- oily solution (Ropivacaine)
Outcomes
Primary Outcome Measures
Incidence of treatment emergent adverse events (safety and tolerability).
All adverse events (AE) reported by the subjects will be recorded throughout the trial period
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01681966
Brief Title
A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 4, 2016 (Actual)
Study Completion Date
May 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PainReform LTD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Application of PRF110- oily solution
Arm Type
Experimental
Arm Description
Post operative application of new extended release PRF110- oily solution (Ropivacaine)
Intervention Type
Drug
Intervention Name(s)
PRF110- oily solution (Ropivacaine)
Other Intervention Name(s)
Ropivacaine oily solution
Intervention Description
Post operative application of PRF110-oily solution (Ropivacaine)
Primary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events (safety and tolerability).
Description
All adverse events (AE) reported by the subjects will be recorded throughout the trial period
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Post-operative Pain intensity
Description
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
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Use of rescue medication
Description
Overall use of rescue medication post operation
Time Frame
72 hours
Title
Maximum plasma concentration (Cmax)
Description
Samples will be collected at designated times up to 72hrs post drug application
Time Frame
72 hrs
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moaad Farraj, Dr.
Organizational Affiliation
Galilee Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Galil Medical Center
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Rishon LeZion
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery
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