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

Egalet

Status and phase

Completed

Phase 3

Conditions

Moderate-to-severe Chronic Low Back Pain

Treatments

Drug: Placebo of oxycodone extended-release

Drug: Oxycodone extended-release

Study type

Interventional

Funder types

Industry

Identifiers

NCT02716857

OC-EG-302

Details and patient eligibility

About

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

Enrollment

549 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.