NCT01681966

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

A Single-dose, Open-Label, Multi-center Study to Assess the Safety and Preliminary Efficacy of PRF 110 (Formerly LNP) in Open Herniorrhaphy Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: PainReform LTD · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	PRF110- oily solution (Ropivacaine)	Post operative application of PRF110-oily solution (Ropivacaine)

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-05-04
• Completion: 2016-05-04
• First posted: 2012-09-10
• Last updated: 2020-11-16

Locations

3 sites across 1 country: Israel