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A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose, Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain and Opioid-Induced Nausea and Vomiting (OINV)

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Trial Profile

A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose, Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain and Opioid-Induced Nausea and Vomiting (OINV)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2018

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At a glance

  • Drugs Promethazine/hydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
  • Indications Nausea and vomiting; Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Acronyms OINV
  • Sponsors Charleston Laboratories; Daiichi Sankyo Company

Most Recent Events

  • 16 Sep 2018 Results assessing the efficacy of CL-108 in Preventing Emetic Episodes During the Treatment of Acute Pain, presented at the 17th World Congress on Pain
  • 16 Sep 2018 Results assessing the effect of CL-108 on Post-Discharge Nausea and Vomiting, presented at the 17th World Congress on Pain
  • 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.

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