Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
- Conditions
- Moderate-to-severe Chronic Low Back Pain
- Interventions
- Drug: Placebo of oxycodone extended-release
- Registration Number
- NCT02716857
- Lead Sponsor
- Egalet Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 549
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxycodone extended-release Oxycodone extended-release Egalet ADER oxycodone tablet Placebo of Oxycodone extended-release Placebo of oxycodone extended-release Egalet ADER oxycodone placebo tablet
- Primary Outcome Measures
Name Time Method Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime. 16 weeks
- Secondary Outcome Measures
Name Time Method Efficacy: daily (past 24 hours) worst pain intensity score (WPI) 16 Weeks 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 16 weeks
Trial Locations
- Locations (74)
Site 245
🇺🇸Boise, Idaho, United States
Site 251
🇺🇸Spartanburg, South Carolina, United States
Site 226
🇺🇸Boston, Massachusetts, United States
Site 277
🇺🇸Overland Park, Kansas, United States
Site 207
🇺🇸Birmingham, Alabama, United States
Site 265
🇺🇸Omaha, Nebraska, United States
Site 269
🇺🇸Inverness, Florida, United States
Site 282
🇺🇸Tucson, Arizona, United States
Site 217
🇺🇸Anaheim, California, United States
Site 209
🇺🇸Franklin, Ohio, United States
Site 259
🇺🇸Kettering, Ohio, United States
Site 239
🇺🇸Oklahoma City, Oklahoma, United States
Site 247
🇺🇸Greenville, South Carolina, United States
Site 219
🇺🇸Richardson, Texas, United States
Site 240
🇺🇸Toledo, Ohio, United States
Site 267
🇺🇸Somerset, New Jersey, United States
Site 205
🇺🇸Charleston, South Carolina, United States
Site 241
🇺🇸Everett, Washington, United States
Site 218
🇺🇸Austin, Texas, United States
Site 257
🇺🇸Spokane, Washington, United States
Site 256
🇺🇸Jenkintown, Pennsylvania, United States
Site 264
🇺🇸Sarasota, Florida, United States
Site 260
🇺🇸Phoenix, Arizona, United States
Site 268
🇺🇸Phoenix, Arizona, United States
Site 280
🇺🇸Anaheim, 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 231
🇺🇸San Diego, California, United States
Site 237
🇺🇸San Diego, California, United States
Site 225
🇺🇸Sacramento, California, United States
Site 221
🇺🇸Wildomar, California, United States
Site 228
🇺🇸Bradenton, Florida, United States
Site 248
🇺🇸Boulder, Colorado, United States
Site 214
🇺🇸Clearwater, Florida, United States
Site 270
🇺🇸Gainesville, Florida, United States
Site 227
🇺🇸Jupiter, Florida, United States
Site 229
🇺🇸Miami Beach, Florida, United States
SIte 204
🇺🇸Lake Worth, Florida, United States
Site 223
🇺🇸Atlanta, Georgia, United States
Site 255
🇺🇸Chicago, Illinois, United States
Site 222
🇺🇸Evansville, Indiana, United States
SIte 236
🇺🇸West Des Moines, Iowa, United States
Site 206
🇺🇸New Orleans, Louisiana, United States
Site 224
🇺🇸Shreveport, Louisiana, United States
Site 249
🇺🇸Pikesville, Maryland, United States
Site 254
🇺🇸New Bedford, Massachusetts, United States
Site 210
🇺🇸Bay City, Michigan, United States
Site 234
🇺🇸Hazelwood, Missouri, United States
Site 261
🇺🇸Kew Gardens, New York, United States
Site 243
🇺🇸New York, New York, United States
Site 208
🇺🇸Williamsville, New York, United States
Site 233
🇺🇸Rochester, New York, United States
Site 203
🇺🇸Charlotte, North Carolina, United States
Site 213
🇺🇸Winston-Salem, North Carolina, United States
Site 276
🇺🇸Columbus, Ohio, United States
Site 242
🇺🇸Winston-Salem, North Carolina, United States
Site 263
🇺🇸Hurst, Texas, United States
Site 202
🇺🇸Mobile, Alabama, United States
Site 278
🇺🇸Plantation, Florida, United States
Site 212
🇺🇸Marietta, Georgia, United States
Site 253
🇺🇸Phoenix, Arizona, United States
Site 258
🇺🇸Lansdale, Pennsylvania, United States
Site 232
🇺🇸Port Orange, Florida, United States
Site 201
🇺🇸Oakland, California, United States
Site 275
🇺🇸San Antonio, Texas, United States
Site 220
🇺🇸La Mesa, California, United States
Site 271
🇺🇸Winter Park, Florida, United States
Site 262
🇺🇸Napa, California, United States
Site 266
🇺🇸Princeton, New Jersey, United States
Site 252
🇺🇸Albuquerque, New Mexico, United States
Site 244
🇺🇸Jackson, Mississippi, United States
Site 279
🇺🇸Duncansville, Pennsylvania, United States
Site 211
🇺🇸Miami Beach, Florida, United States