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)

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)

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Feb 2017

At a glance

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

    • 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 (n=502) presented at the 16th World Congress on Pain.
    • 30 Sep 2016 Results evaluating clinically significant relief in patients with moderate-to-severe pain (n=302) presented at the 16th World Congress on Pain
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