NCT02716857

Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain

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: Phase 3
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: Egalet Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the analgesic efficacy of Egalet-002 twice daily (BID) in patients with moderate-to-severe chronic low back pain

Conditions

• Moderate-to-severe Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Oxycodone extended-release
DRUG	Placebo of oxycodone extended-release

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-08-01
• Completion: 2017-11-01
• First posted: 2016-03-23
• Last updated: 2018-03-05

Locations

74 sites across 1 country: United States