Clinical trial NCT02603705: Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain
Official title: An Open-label Phase 3 Trial to Evaluate the Safety and Tolerability of Egalet ADER Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Noncancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate-to-severe Chronic Noncancer Pain
Keywords: chronic pain
opioid
oxycodone
non cancer pain
moderate to severe
Lead sponsor: Egalet Ltd
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of TEAEs during the Open-label Treatment Period, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment
timeFrame: 1 year
Secondary outcomes:
measure: Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period
timeFrame: 1 year
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site 334
state: Alabama
city: Tucson
country: United States
facility: Site 328
state: Arizona
city: Jacksonville
country: United States
facility: Site 332
state: Florida
city: Miami Gardens
country: United States
facility: Site 340
state: Florida
city: Plantation
country: United States
facility: Site 320
state: Florida
city: Tampa
country: United States
facility: Site 302
state: Florida
city: Tampa
country: United States
facility: Site 315
state: Florida
city: Winter Haven
country: United States
facility: Site 310
state: Florida
city: Dawsonville
country: United States
facility: Site 316
state: Georgia
city: Marietta
country: United States
facility: Site 311
state: Georgia
city: Bloomington
country: United States
facility: Site 336
state: Illinois
city: Blue Island
country: United States
facility: Site 345
state: Illinois
city: Evansville
country: United States
facility: Site 304
state: Indiana
city: Valparaiso
country: United States
facility: Site 325
state: Indiana
city: Overland Park
country: United States
facility: Site 321
state: Kansas
city: Wichita
country: United States
facility: Site 342
state: Kansas
city: New Orleans
country: United States
facility: Site 329
state: Louisiana
city: Quincy
country: United States
facility: Site 326
state: Massachusetts
city: Saint Louis
country: United States
facility: Site 303
state: Missouri
city: Las Vegas
country: United States
facility: Site 306
state: Nevada
city: Belvidere
country: United States
facility: Site 313
state: New Jersey
city: Blackwood
country: United States
facility: Site 346
state: New Jersey
city: Hartsdale
country: United States
facility: Site 323
state: New York
city: Mooresville
country: United States
facility: Site 338
state: North Carolina
city: Cincinnati
country: United States
facility: Site 333
state: Ohio
city: Cleveland
country: United States
facility: Site 343
state: Ohio
city: Huber Heights
country: United States
facility: Site 308
state: Ohio
city: Kettering
country: United States
facility: Site 347
state: Ohio
city: Oklahoma City
country: United States
facility: Site 335
state: Oklahoma
city: Eugene
country: United States
facility: Site 312
state: Oregon
city: Duncansville
country: United States
facility: Site 322
state: Pennsylvania
city: Wyomissing
country: United States
facility: Site 324
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Site 344
state: South Carolina
city: Summerville
country: United States
facility: Site 314
state: South Carolina
city: New Tazewell
country: United States
facility: Site 341
state: Tennessee
city: Austin
country: United States
facility: Site 318
state: Texas
city: Dallas
country: United States
facility: Site 330
state: Texas
city: San Antonio
country: United States
facility: Site 309
state: Texas
city: West Jordan
country: United States
facility: Site 331
state: Utah
Study officials:
References: