A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by PainReform LTD
Sponsor:
Information provided by (Responsible Party):
PainReform LTD
ClinicalTrials.gov Identifier:
NCT01681966
First received: September 5, 2012
Last updated: November 22, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Post Operative Pain
Drug: PRF110- oily solution (Ropivacaine)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by PainReform LTD:

Primary Outcome Measures:
  • Incidence of treatment emergent adverse events (safety and tolerability). [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    All adverse events (AE) reported by the subjects will be recorded throughout the trial period


Secondary Outcome Measures:
  • Post-operative Pain intensity [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Use of rescue medication [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Overall use of rescue medication post operation

  • Maximum plasma concentration (Cmax) [ Time Frame: 72 hrs ] [ Designated as safety issue: Yes ]
    Samples will be collected at designated times up to 72hrs post drug application


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Application of PRF110- oily solution
Post operative application of new extended release PRF110- oily solution (Ropivacaine)
Drug: PRF110- oily solution (Ropivacaine)
Post operative application of PRF110-oily solution (Ropivacaine)
Other Name: Ropivacaine oily solution

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681966

Contacts
Contact: Sigal Aviel, Dr. +972-9-9601911 saviel@painreform.com

Locations
Israel
Western Galil Medical Center Recruiting
Naharia, Israel, 2210001
Contact: Moaad Faraj, Dr.    +972-4-9107157    moaad.farraj@naharia.health.il   
Principal Investigator: Moaad Farraj, Dr.         
Sponsors and Collaborators
PainReform LTD
Investigators
Principal Investigator: Moaad Farraj, Dr. Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: PainReform LTD
ClinicalTrials.gov Identifier: NCT01681966     History of Changes
Other Study ID Numbers: LNP-IL102 
Study First Received: September 5, 2012
Last Updated: November 22, 2015
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Pharmaceutical Solutions
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 03, 2016