Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
NCT ID: NCT02716857
Last Updated: 2018-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
549 participants
INTERVENTIONAL
2016-03-31
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oxycodone extended-release
Egalet ADER oxycodone tablet
Oxycodone extended-release
Placebo of Oxycodone extended-release
Egalet ADER oxycodone placebo tablet
Placebo of oxycodone extended-release
Interventions
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Oxycodone extended-release
Placebo of oxycodone extended-release
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Egalet Ltd
INDUSTRY
Responsible Party
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Locations
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Site 207
Birmingham, Alabama, United States
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 211
Miami Beach, Florida, United States
Site 229
Miami Beach, Florida, United States
Site 278
Plantation, Florida, United States
Site 232
Port Orange, Florida, United States
Site 264
Sarasota, Florida, United States
Site 271
Winter Park, Florida, United States
Site 223
Atlanta, Georgia, United States
Site 212
Marietta, Georgia, United States
Site 245
Boise, Idaho, United States
Site 255
Chicago, Illinois, United States
Site 222
Evansville, Indiana, United States
SIte 236
West Des Moines, Iowa, United States
Site 277
Overland Park, Kansas, United States
Site 206
New Orleans, Louisiana, United States
Site 224
Shreveport, Louisiana, United States
Site 249
Pikesville, Maryland, United States
Site 226
Boston, Massachusetts, United States
Site 254
New Bedford, Massachusetts, United States
Site 210
Bay City, Michigan, United States
Site 244
Jackson, Mississippi, United States
Site 234
Hazelwood, Missouri, United States
Site 265
Omaha, Nebraska, United States
Site 266
Princeton, New Jersey, United States
Site 267
Somerset, New Jersey, United States
Site 252
Albuquerque, New Mexico, United States
Site 261
Kew Gardens, New York, United States
Site 243
New York, New York, United States
Site 233
Rochester, New York, United States
Site 208
Williamsville, New York, United States
Site 203
Charlotte, North Carolina, United States
Site 213
Winston-Salem, North Carolina, United States
Site 242
Winston-Salem, North Carolina, United States
Site 276
Columbus, Ohio, United States
Site 209
Franklin, Ohio, United States
Site 259
Kettering, Ohio, United States
Site 240
Toledo, Ohio, United States
Site 239
Oklahoma City, Oklahoma, United States
Site 279
Duncansville, Pennsylvania, United States
Site 256
Jenkintown, Pennsylvania, United States
Site 258
Lansdale, Pennsylvania, United States
Site 205
Charleston, South Carolina, United States
Site 247
Greenville, South Carolina, United States
Site 251
Spartanburg, South Carolina, United States
Site 218
Austin, Texas, United States
Site 263
Hurst, Texas, United States
Site 219
Richardson, Texas, United States
Site 275
San Antonio, Texas, United States
Site 241
Everett, Washington, United States
Site 257
Spokane, Washington, United States
Countries
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Other Identifiers
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OC-EG-302
Identifier Type: -
Identifier Source: org_study_id
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