drugset / Trial / NCT03797612
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brivoligide | Unknown | 660 mg | Intrathecal |