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A Phase 3 Study multi-center, randomized, double-blind, safety and efficacy trial of mdc-CWM for Post-Operative Pain and Inflammation

Trial Profile

A Phase 3 Study multi-center, randomized, double-blind, safety and efficacy trial of mdc-CWM for Post-Operative Pain and Inflammation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2024

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At a glance

  • Drugs Celecoxib (Primary)
  • Indications Inflammation; Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Arthritis Innovation Corporation

Most Recent Events

  • 03 Sep 2024 According to MedinCell media release, the company plans to meet with FDA in Q4 2024 to discuss additional studies required for approval.
  • 03 Sep 2024 Status changed from active, no longer recruiting to completed., as per Medincell media release.
  • 14 May 2024 Primary endpoint (time-weighted AUC of pain intensity over 14 days when comparing treatment with multimodal analgesia (MMA) alone to MMA concurrent with a single dose of F14 administered in the knee at the time of Total Knee Replacement (TKR).) has not been met as per MedinCell Media Release

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