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A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain

NCT05773846 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 428

Last updated 2024-09-19

No results posted yet for this study

Summary

PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia. The pharmacokinetic profile for PRF-110 suggests that its effect could last up to 72 hours. This is A Phase 3, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study to Evaluate the Analgesic Efficacy and Safety of Intra-operative Administration of PRF-110 Following Unilateral Bunionectomy

Conditions

  • Bunion

Interventions

DRUG

Ropivacaine

A long acting formulation of ropivacaine

Sponsors & Collaborators

  • Lotus Clinical Research, LLC

    collaborator OTHER

  • PainReform LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2024-07-30
Completion
2024-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05773846 on ClinicalTrials.gov