A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

Trial Profile

A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2017

At a glance

  • Drugs Promethazine/hydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
  • Indications Nausea and vomiting; Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Charleston Laboratories; Daiichi Sankyo Company
  • 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.
    • 02 Nov 2016 Status changed from discontinued to completed.
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