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A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement

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A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement

Status: Withdrawn prior to enrolment
Phase of Trial: Phase II

Latest Information Update: 15 Jul 2020

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At a glance

  • Drugs Brivoligide (Primary)
  • Indications Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Adynxx

    • Most Recent Events

    • 09 Jul 2020 Planned End Date changed from 1 Dec 2020 to 1 Feb 2022.
    • 09 Jul 2020 Planned primary completion date changed from 1 Dec 2020 to 1 Jan 2022.
    • 09 Jul 2020 Planned initiation date changed from 1 Dec 2019 to 1 Jan 2021.

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