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

NCT04104919 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-07-13

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Brivoligide Injection 660 mg/6 mL

Single preoperative intrathecal injection

DRUG

Placebo 6 mL

Single preoperative intrathecal injection

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Adynxx, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2022-01-31
Completion
2022-02-28
FDA Drug
Yes

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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 NCT04104919 on ClinicalTrials.gov