Moderate-to-severe Chronic Low Back Pain Clinical Trial
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
| Verified date | March 2018 |
| Source | Egalet Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 549 |
| Est. completion date | November 2017 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 252 | Albuquerque | New Mexico |
| United States | Site 217 | Anaheim | California |
| United States | Site 280 | Anaheim | California |
| United States | Site 223 | Atlanta | Georgia |
| United States | Site 218 | Austin | Texas |
| United States | Site 210 | Bay City | Michigan |
| United States | Site 207 | Birmingham | Alabama |
| United States | Site 245 | Boise | Idaho |
| United States | Site 226 | Boston | Massachusetts |
| United States | Site 248 | Boulder | Colorado |
| United States | Site 228 | Bradenton | Florida |
| United States | Site 205 | Charleston | South Carolina |
| United States | Site 203 | Charlotte | North Carolina |
| United States | Site 255 | Chicago | Illinois |
| United States | Site 214 | Clearwater | Florida |
| United States | Site 276 | Columbus | Ohio |
| United States | Site 279 | Duncansville | Pennsylvania |
| United States | Site 222 | Evansville | Indiana |
| United States | Site 241 | Everett | Washington |
| United States | Site 209 | Franklin | Ohio |
| United States | Site 270 | Gainesville | Florida |
| United States | Site 247 | Greenville | South Carolina |
| United States | Site 234 | Hazelwood | Missouri |
| United States | Site 263 | Hurst | Texas |
| United States | Site 269 | Inverness | Florida |
| United States | Site 244 | Jackson | Mississippi |
| United States | Site 256 | Jenkintown | Pennsylvania |
| United States | Site 227 | Jupiter | Florida |
| United States | Site 259 | Kettering | Ohio |
| United States | Site 261 | Kew Gardens | New York |
| United States | Site 220 | La Mesa | California |
| United States | Site 235 | Laguna Hills | California |
| United States | SIte 204 | Lake Worth | Florida |
| United States | Site 258 | Lansdale | Pennsylvania |
| United States | Site 215 | Long Beach | California |
| United States | Site 238 | Los Gatos | California |
| United States | Site 212 | Marietta | Georgia |
| United States | Site 211 | Miami Beach | Florida |
| United States | Site 229 | Miami Beach | Florida |
| United States | Site 202 | Mobile | Alabama |
| United States | Site 262 | Napa | California |
| United States | Site 254 | New Bedford | Massachusetts |
| United States | Site 206 | New Orleans | Louisiana |
| United States | Site 243 | New York | New York |
| United States | Site 201 | Oakland | California |
| United States | Site 239 | Oklahoma City | Oklahoma |
| United States | Site 265 | Omaha | Nebraska |
| United States | Site 277 | Overland Park | Kansas |
| United States | Site 253 | Phoenix | Arizona |
| United States | Site 260 | Phoenix | Arizona |
| United States | Site 268 | Phoenix | Arizona |
| United States | Site 249 | Pikesville | Maryland |
| United States | Site 278 | Plantation | Florida |
| United States | Site 232 | Port Orange | Florida |
| United States | Site 266 | Princeton | New Jersey |
| United States | Site 219 | Richardson | Texas |
| United States | Site 233 | Rochester | New York |
| United States | Site 225 | Sacramento | California |
| United States | Site 275 | San Antonio | Texas |
| United States | Site 231 | San Diego | California |
| United States | Site 237 | San Diego | California |
| United States | Site 264 | Sarasota | Florida |
| United States | Site 224 | Shreveport | Louisiana |
| United States | Site 267 | Somerset | New Jersey |
| United States | Site 251 | Spartanburg | South Carolina |
| United States | Site 257 | Spokane | Washington |
| United States | Site 240 | Toledo | Ohio |
| United States | Site 282 | Tucson | Arizona |
| United States | SIte 236 | West Des Moines | Iowa |
| United States | Site 221 | Wildomar | California |
| United States | Site 208 | Williamsville | New York |
| United States | Site 213 | Winston-Salem | North Carolina |
| United States | Site 242 | Winston-Salem | North Carolina |
| United States | Site 271 | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Egalet Ltd |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime. | 16 weeks | ||
| Secondary | Efficacy: daily (past 24 hours) worst pain intensity score (WPI) | 16 Weeks | ||
| Secondary | 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 |