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)
Phase of Trial: Phase III
Latest Information Update: 17 Oct 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
- 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.
- 30 Sep 2016 Results (n=502) presented at the 16th World Congress on Pain.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History