Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain

Completed · Phase 3

Conditions studied: Moderate-to-severe Chronic Noncancer Pain

In brief

The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in opioid-experienced patients with moderate-to-severe chronic noncancer pain.

Key facts

Study ID

NCT02603705

Run by

Egalet Ltd

People needed

281

Starts

2016-03-07

Expected to finish

2017-06-15

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 a man or woman between 18 and 75 years of age.
• Has a clinical history of moderate-to-severe chronic noncancer pain ≥6 months.
• Has required opioid therapy for at least 14 days prior to Screening at a dose between 20 mg and 160 mg (inclusive) oxycodone/day (or opioid equivalent), and will, in the opinion of the investigator, continue to require opioid therapy (between 20 mg and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe pain for the duration of the study.
• Has pain either not adequately controlled on current opioid regimen, requires a change of opioid due to tolerability of current opioid regimen or in the opinion of the investigator, would benefit from changing opioid for another reason.
• 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 through the duration of the study), or is of non-childbearing potential.
• Other Criteria Apply

You may not qualify if…

• Has cancer-related pain.
• Is receiving >240 mg oxycodone daily (or opioid equivalent) within 30 days before Screening.
• Has a history of attempted suicide.
• Has used a spinal infusion pump within 6 months before Screening.
• Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) and/or respiratory disease (including chronic obstructive pulmonary disease or sleep apnea).
• Has positive urine toxicity screen for drugs of abuse (with the exception of prescribed medications).
• Has positive result for tetrahydrocannabinol (even if legally prescribed).
• Has current (or history of within the last 12 months) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
• Other Criteria Apply

Where it is running

• Site 334 — Huntsville, Alabama, United States
• Site 328 — Tucson, Arizona, United States
• Site 332 — Jacksonville, Florida, United States
• Site 340 — Miami Gardens, Florida, United States
• Site 320 — Plantation, Florida, United States
• Site 302 — Tampa, Florida, United States
• Site 315 — Tampa, Florida, United States
• Site 310 — Winter Haven, Florida, United States
• Site 316 — Dawsonville, Georgia, United States
• Site 311 — Marietta, Georgia, United States
• Site 336 — Bloomington, Illinois, United States
• Site 345 — Blue Island, Illinois, United States
• Site 304 — Evansville, Indiana, United States
• Site 325 — Valparaiso, Indiana, United States
• Site 321 — Overland Park, Kansas, United States
• Site 342 — Wichita, Kansas, United States
• Site 329 — New Orleans, Louisiana, United States
• Site 326 — Quincy, Massachusetts, United States
• Site 303 — St Louis, Missouri, United States
• Site 306 — Las Vegas, Nevada, United States
• Site 313 — Belvidere, New Jersey, United States
• Site 346 — Blackwood, New Jersey, United States
• Site 323 — Hartsdale, New York, United States
• Site 338 — Mooresville, North Carolina, United States
• Site 333 — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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