Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

Next Previous
Trial Profile

A Phase 3 Multi-Center Actual-Use Study on the Safety of CL 108 for the Treatment of Moderate to Severe Acute Pain Associated With Osteoarthritis of the Knee or Hip

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Oct 2017

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Promethazine/hydrocodone/paracetamol (Primary)
  • Indications Musculoskeletal pain
  • Focus Adverse reactions; Registrational
  • Sponsors Charleston Laboratories

    • Most Recent Events

    • 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 presented at the 16th World Congress on Pain
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top