Clinical trial NCT01681966: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Operative Pain
Lead sponsor: PainReform LTD
Sponsor class: INDUSTRY
First posted: 2012-09-10
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Incidence of treatment emergent adverse events (safety and tolerability).
timeFrame: 72 hours
Secondary outcomes:
measure: Post-operative Pain intensity
timeFrame: 72 hours
Other outcomes:
measure: Use of rescue medication
timeFrame: 72 hours
measure: Maximum plasma concentration (Cmax)
timeFrame: 72 hrs
Locations:
city: Nahariya
country: Israel
facility: Western Galil Medical Center
city: Rishon LeZion
country: Israel
facility: Assaf Harofeh Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Galilee Medical Center
name: Moaad Farraj, Dr.
role: PRINCIPAL_INVESTIGATOR
References: