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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Egalet Ltd
• Treatments: Oxycodone

Criteria

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.