Trial Profile
A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Egalet Abuse-deterrent, Extended-release (ADER) Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Low Back Pain
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 11 Jul 2019
Price :
$35
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At a glance
- Drugs Oxycodone (Primary)
- Indications Back pain
- Focus Registrational; Therapeutic Use
- Sponsors Zyla Life Sciences
- 02 Mar 2018 Status changed from active, no longer recruiting to completed.
- 28 Nov 2017 Primary endpoint (Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.) has been met, according to an Egalet Corporation media release.
- 16 Nov 2017 According to an Egalet media release, this study is expected to be completed by year end.