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

CompletedPhase 3NCT02716857
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
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
Conditions
  • Moderate-to-severe Chronic Low Back Pain
Interventions
  • Drug: Oxycodone extended-release
  • Drug: Placebo of oxycodone extended-release
Sponsor
Egalet Ltd
Start date
2016-03
Primary completion
2017-08
Sex
All
Age range
from 18 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
74

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Is an English-speaking man or woman between 18 and 75 years of age who has given written informed consent. * Has a clinical diagnosis of moderate-to-severe low back pain (Quebec Task Force Class 1 to 3) for ≥6 months. * Is opioid naïve (ie, taking \<20 mg oxycodone/day or opioid equivalent) or is opioid experienced (ie, taking a dose between 20 and 240 mg \[inclusive\] oxycodone/day or opioid equivalent) for management of moderate-to-severe CLBP at least 14 days prior to screening and will, in the opinion of the investigator, continue to require opioid therapy (between 20 and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe CLBP for the duration of the study. * Has stable health, as determined by the investigator, * If female, the patient is currently not pregnant, not breast-feeding, nor attempting to become pregnant (for 30 days before screening and throughout the duration of the study), or is of non-childbearing potential Exclusion Criteria: * Has cancer-related pain. * Has a history of receiving \>240 mg oxycodone (or equivalent) daily within 30 days before screening. * Has a lumbar spinal infusion pump in use or used within 6 months before screening. * Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) * Has positive urine drug toxicity screen for illegal or non-prescribed drugs * Has current (or history of within the last 5 years prior to screening) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine). * Has positive result for cannabinoids (even if legally prescribed). * Has a history of attempted suicide.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02716857