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
Price :
$35
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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
- 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.