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A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Acute Pain and the Prevention of Opioid-Induced Nausea and Vomiting (OINV)

Trial Profile

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Acute Pain and the Prevention of Opioid-Induced Nausea and Vomiting (OINV)

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2019

At a glance

  • Drugs Promethazine/hydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
  • Indications Acute pain; Nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Charleston Laboratories
  • Most Recent Events

    • 02 Jan 2019 Status changed from active, no longer recruiting to completed.
    • 10 Sep 2018 New trial record
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