A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
Phase of Trial: Phase III
Latest Information Update: 03 Feb 2017
At a glance
- Drugs Promethazine/hydrocodone/paracetamol (Primary) ; Hydrocodone/paracetamol
- Indications Nausea and vomiting; Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors Charleston Laboratories; Daiichi Sankyo Company
- 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.
- 02 Nov 2016 Status changed from discontinued to completed.
- 13 Jun 2016 According to a Charleston Laboratories media release, the US FDA has accepted for review the NDA for CL-108 for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV). The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 31, 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History