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drugset / Trial / NCT04104919

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

NCT04104919 ↗

Phase 2 Withdrawn Adynxx, Inc. National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a multiple center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with high Pain Catastrophizing Scale (PCS) scores undergoing mastectomy with immediate tissue expander or implant placement.

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

No indication recorded.