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A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

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Trial Profile

A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Oct 2017

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At a glance

  • Drugs Promethazine/hydrocodone/paracetamol (Primary)
  • Indications Musculoskeletal pain
  • Focus Adverse reactions; Registrational
  • Sponsors Charleston Laboratories

    • Most Recent Events

    • 17 Oct 2017 According to a Charleston Laboratories media release, the company has resubmitted the new drug application (NDA) for its novel investigational treatment, CL-108, for the relief of moderate to severe acute pain while preventing and reducing opioid-induced nausea and vomiting (OINV) for patients with pain severe enough to require an opioid.
    • 03 Feb 2017 According to a Charleston Laboratories and Daiichi Sankyo media release, the U.S. FDA has issued a Complete Response Letter (CRL) regarding the NDA for CL-108. The CRL stated that the NDA in its present form was not approved and provided guidance on information needed to resolve matters identified.
    • 30 Sep 2016 Results presented at the 16th World Congress on Pain

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