Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain

NCT02716857 | Completed Phase 3

• 1 other identifier: OC-EG-302
• Study Type: interventional
• Target: 549
• Locations: 1 country
• Sites: 74

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

Conditions

Moderate-to-severe Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.

  16 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Oxycodone extended-release

EXPERIMENTAL

Egalet ADER oxycodone tablet

Drug: Oxycodone extended-release

Placebo of Oxycodone extended-release

PLACEBO COMPARATOR

Egalet ADER oxycodone placebo tablet

Drug: Placebo of oxycodone extended-release

Interventions

Oxycodone extended-release DRUG

Also known as: Egalet-002, Egalet ADER oxycodone

Oxycodone extended-release

Placebo of oxycodone extended-release DRUG

Placebo of Oxycodone extended-release

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egalet Ltd: lead

Study Sites (74)

Site 207

Birmingham, Alabama, 35209, United States

Location

Site 202

Mobile, Alabama, 36608, United States

Location

Site 253

Phoenix, Arizona, 85018, United States

Location

Site 260

Phoenix, Arizona, 85018, United States

Location

Site 268

Phoenix, Arizona, 85029, United States

Location

Site 282

Tucson, Arizona, 85704, United States

Location

Site 217

Anaheim, California, 92801, United States

Location

Site 280

Anaheim, California, 92804, United States

Location

Site 220

La Mesa, California, 91942, United States

Location

Site 235

Laguna Hills, California, 92637, United States

Location

Site 215

Long Beach, California, 90806, United States

Location

Site 238

Los Gatos, California, 95032, United States

Location

Site 262

Napa, California, 94558, United States

Location

Site 201

Oakland, California, 94607, United States

Location

Site 225

Sacramento, California, 95831, United States

Location

Site 231

San Diego, California, 92105, United States

Location

Site 237

San Diego, California, 92120, United States

Location

Site 221

Wildomar, California, 92595, United States

Location

Site 248

Boulder, Colorado, 80301, United States

Location

Site 228

Bradenton, Florida, 34205, United States

Location

Site 214

Clearwater, Florida, 33765, United States

Location

Site 270

Gainesville, Florida, 32607, United States

Location

Site 269

Inverness, Florida, 34452, United States

Location

Site 227

Jupiter, Florida, 33458, United States

Location

SIte 204

Lake Worth, Florida, 33462, United States

Location

Site 211

Miami Beach, Florida, 33140, United States

Location

Site 229

Miami Beach, Florida, 33140, United States

Location

Site 278

Plantation, Florida, 33317, United States

Location

Site 232

Port Orange, Florida, 32129, United States

Location

Site 264

Sarasota, Florida, 34232, United States

Location

Site 271

Winter Park, Florida, 32789, United States

Location

Site 223

Atlanta, Georgia, 30309, United States

Location

Site 212

Marietta, Georgia, 30060, United States

Location

Site 245

Boise, Idaho, 83713, United States

Location

Site 255

Chicago, Illinois, 60614, United States

Location

Site 222

Evansville, Indiana, 47714, United States

Location

SIte 236

West Des Moines, Iowa, 50265, United States

Location

Site 277

Overland Park, Kansas, 66210, United States

Location

Site 206

New Orleans, Louisiana, 70115, United States

Location

Site 224

Shreveport, Louisiana, 71105, United States

Location

Site 249

Pikesville, Maryland, 21208, United States

Location

Site 226

Boston, Massachusetts, 02135, United States

Location

Site 254

New Bedford, Massachusetts, 02740, United States

Location

Site 210

Bay City, Michigan, 48706, United States

Location

Site 244

Jackson, Mississippi, 39202, United States

Location

Site 234

Hazelwood, Missouri, 63042, United States

Location

Site 265

Omaha, Nebraska, 68114, United States

Location

Site 266

Princeton, New Jersey, 08540, United States

Location

Site 267

Somerset, New Jersey, 08873, United States

Location

Site 252

Albuquerque, New Mexico, 87102, United States

Location

Site 261

Kew Gardens, New York, 11415, United States

Location

Site 243

New York, New York, 10019, United States

Location

Site 233

Rochester, New York, 14618, United States

Location

Site 208

Williamsville, New York, 14221, United States

Location

Site 203

Charlotte, North Carolina, 28209, United States

Location

Site 213

Winston-Salem, North Carolina, 27103, United States

Location

Site 242

Winston-Salem, North Carolina, 27103, United States

Location

Site 276

Columbus, Ohio, 43210, United States

Location

Site 209

Franklin, Ohio, 45005, United States

Location

Site 259

Kettering, Ohio, 45429, United States

Location

Site 240

Toledo, Ohio, 43623, United States

Location

Site 239

Oklahoma City, Oklahoma, 73119, United States

Location

Site 279

Duncansville, Pennsylvania, 16635, United States

Location

Site 256

Jenkintown, Pennsylvania, 19046, United States

Location

Site 258

Lansdale, Pennsylvania, 19446, United States

Location

Site 205

Charleston, South Carolina, 29406, United States

Location

Site 247

Greenville, South Carolina, 29601, United States

Location

Site 251

Spartanburg, South Carolina, 29303, United States

Location

Site 218

Austin, Texas, 78704, United States

Location

Site 263

Hurst, Texas, 76054, United States

Location

Site 219

Richardson, Texas, 75080, United States

Location

Site 275

San Antonio, Texas, 78207, United States

Location

Site 241

Everett, Washington, 98201, United States

Location

Site 257

Spokane, Washington, 99202, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (74)