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

Trial Profile

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

Completed
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
  • 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.
    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top