Phase 2Completed
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
- Sponsor
- PainReform LTD (Industry)
- Enrollment
- 15 enrolled
- Conditions
- Post Operative Pain
- Interventions
- PRF110- oily solution (Ropivacaine)
- Ages
- adults, older adults
- Registry
- NCT01681966
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Incidence of treatment emergent adverse events (safety and tolerability).
History
Last registry update
Primary completion
Started
Registered