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

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate-to-severe Chronic Low Back Pain

In brief

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

Key facts

Study ID

NCT02716857

Run by

Egalet Ltd

People needed

549

Starts

2016-03-01

Expected to finish

2017-11-01

Last updated by the study team

2018-03-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Site 202 — Mobile, Alabama, United States
• Site 253 — Phoenix, Arizona, United States
• Site 260 — Phoenix, Arizona, United States
• Site 268 — Phoenix, Arizona, United States
• Site 282 — Tucson, Arizona, United States
• Site 217 — Anaheim, California, United States
• Site 280 — Anaheim, California, United States
• Site 220 — La Mesa, California, United States
• Site 235 — Laguna Hills, California, United States
• Site 215 — Long Beach, California, United States
• Site 238 — Los Gatos, California, United States
• Site 262 — Napa, California, United States
• Site 201 — Oakland, California, United States
• Site 225 — Sacramento, California, United States
• Site 231 — San Diego, California, United States
• Site 237 — San Diego, California, United States
• Site 221 — Wildomar, California, United States
• Site 248 — Boulder, Colorado, United States
• Site 228 — Bradenton, Florida, United States
• Site 214 — Clearwater, Florida, United States
• Site 270 — Gainesville, Florida, United States
• Site 269 — Inverness, Florida, United States
• Site 227 — Jupiter, Florida, United States
• SIte 204 — Lake Worth, Florida, United States
• Site 207 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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