Clinical trial NCT02716857: Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
Official title: A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Egalet® Abuse-deterrent, Extended-release (ADER) Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate-to-severe Chronic Low Back Pain
Lead sponsor: Egalet Ltd
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.
timeFrame: 16 weeks
Secondary outcomes:
measure: Efficacy: daily (past 24 hours) worst pain intensity score (WPI)
timeFrame: 16 Weeks
measure: Safety: Incidence of TEAEs, 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: 16 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 207
state: Alabama
city: Mobile
country: United States
facility: Site 202
state: Alabama
city: Phoenix
country: United States
facility: Site 253
state: Arizona
city: Phoenix
country: United States
facility: Site 260
state: Arizona
city: Phoenix
country: United States
facility: Site 268
state: Arizona
city: Tucson
country: United States
facility: Site 282
state: Arizona
city: Anaheim
country: United States
facility: Site 217
state: California
city: Anaheim
country: United States
facility: Site 280
state: California
city: La Mesa
country: United States
facility: Site 220
state: California
city: Laguna Hills
country: United States
facility: Site 235
state: California
city: Long Beach
country: United States
facility: Site 215
state: California
city: Los Gatos
country: United States
facility: Site 238
state: California
city: Napa
country: United States
facility: Site 262
state: California
city: Oakland
country: United States
facility: Site 201
state: California
city: Sacramento
country: United States
facility: Site 225
state: California
city: San Diego
country: United States
facility: Site 231
state: California
city: San Diego
country: United States
facility: Site 237
state: California
city: Wildomar
country: United States
facility: Site 221
state: California
city: Boulder
country: United States
facility: Site 248
state: Colorado
city: Bradenton
country: United States
facility: Site 228
state: Florida
city: Clearwater
country: United States
facility: Site 214
state: Florida
city: Gainesville
country: United States
facility: Site 270
state: Florida
city: Inverness
country: United States
facility: Site 269
state: Florida
city: Jupiter
country: United States
facility: Site 227
state: Florida
city: Lake Worth
country: United States
facility: SIte 204
state: Florida
city: Miami Beach
country: United States
facility: Site 211
state: Florida
city: Miami Beach
country: United States
facility: Site 229
state: Florida
city: Plantation
country: United States
facility: Site 278
state: Florida
city: Port Orange
country: United States
facility: Site 232
state: Florida
city: Sarasota
country: United States
facility: Site 264
state: Florida
city: Winter Park
country: United States
facility: Site 271
state: Florida
city: Atlanta
country: United States
facility: Site 223
state: Georgia
city: Marietta
country: United States
facility: Site 212
state: Georgia
city: Boise
country: United States
facility: Site 245
state: Idaho
city: Chicago
country: United States
facility: Site 255
state: Illinois
city: Evansville
country: United States
facility: Site 222
state: Indiana
city: West Des Moines
country: United States
facility: SIte 236
state: Iowa
city: Overland Park
country: United States
facility: Site 277
state: Kansas
city: New Orleans
country: United States
facility: Site 206
state: Louisiana
city: Shreveport
country: United States
facility: Site 224
state: Louisiana
city: Pikesville
country: United States
facility: Site 249
state: Maryland
city: Boston
country: United States
facility: Site 226
state: Massachusetts
city: New Bedford
country: United States
facility: Site 254
state: Massachusetts
city: Bay City
country: United States
facility: Site 210
state: Michigan
city: Jackson
country: United States
facility: Site 244
state: Mississippi
city: Hazelwood
country: United States
facility: Site 234
state: Missouri
city: Omaha
country: United States
facility: Site 265
state: Nebraska
city: Princeton
country: United States
facility: Site 266
state: New Jersey
city: Somerset
country: United States
facility: Site 267
state: New Jersey
city: Albuquerque
country: United States
facility: Site 252
state: New Mexico
city: Kew Gardens
country: United States
facility: Site 261
state: New York
city: New York
country: United States
facility: Site 243
state: New York
city: Rochester
country: United States
facility: Site 233
state: New York
city: Williamsville
country: United States
facility: Site 208
state: New York
city: Charlotte
country: United States
facility: Site 203
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 213
state: North Carolina
city: Winston-Salem
country: United States
facility: Site 242
state: North Carolina
city: Columbus
country: United States
facility: Site 276
state: Ohio
city: Franklin
country: United States
facility: Site 209
state: Ohio
city: Kettering
country: United States
facility: Site 259
state: Ohio
city: Toledo
country: United States
facility: Site 240
state: Ohio
city: Oklahoma City
country: United States
facility: Site 239
state: Oklahoma
city: Duncansville
country: United States
facility: Site 279
state: Pennsylvania
city: Jenkintown
country: United States
facility: Site 256
state: Pennsylvania
city: Lansdale
country: United States
facility: Site 258
state: Pennsylvania
city: Charleston
country: United States
facility: Site 205
state: South Carolina
city: Greenville
country: United States
facility: Site 247
state: South Carolina
city: Spartanburg
country: United States
facility: Site 251
state: South Carolina
city: Austin
country: United States
facility: Site 218
state: Texas
city: Hurst
country: United States
facility: Site 263
state: Texas
city: Richardson
country: United States
facility: Site 219
state: Texas
city: San Antonio
country: United States
facility: Site 275
state: Texas
city: Everett
country: United States
facility: Site 241
state: Washington
city: Spokane
country: United States
facility: Site 257
state: Washington
Study officials:
References: