drugset / Trial / NCT03797612

Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores

NCT03797612 ↗

Phase 2 Withdrawn Adynxx, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with a Pain Catastrophizing Scale (PCS) score ≥16 undergoing primary unilateral total knee arthroplasty.

Timeline

Start
2021-01
Primary completion
2022-01
Completion
2022-02

Outcome

Outcome not reported

Stopped: “Study initiation delayed due to COVID 19”

Drugs

EvaluationDrugModalityDoseRoute
Subject Brivoligide Unknown 660 mg Intrathecal

Indications