A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain
Phase of Trial: Phase III
Latest Information Update: 06 Apr 2017
At a glance
- Drugs Oxycodone/naltrexone (Primary)
- Indications Back pain
- Focus Registrational; Therapeutic Use
- Sponsors Pfizer
- 06 Apr 2017 Last checked against ClinicalTrials.gov record.
- 19 Aug 2016 According to a Pfizer media release, the US FDA has approved Troxyca ER (oxycodone/naltrexone) for oral use, with the abuse-deterrent properties for the management of pain.
- 28 Apr 2015 According to a Pfizer media release, the US FDA has assigned a PDUFA action date in October 2015 for the NDA for oxycodone/naltrexone [ALO 02] for the treatment of severe pain.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History