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

March 2, 2018 updated by: Egalet Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

549

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Site 207
      • Mobile, Alabama, United States, 36608
        • Site 202
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Site 253
      • Phoenix, Arizona, United States, 85018
        • Site 260
      • Phoenix, Arizona, United States, 85029
        • Site 268
      • Tucson, Arizona, United States, 85704
        • Site 282
    • California
      • Anaheim, California, United States, 92801
        • Site 217
      • Anaheim, California, United States, 92804
        • Site 280
      • La Mesa, California, United States, 91942
        • Site 220
      • Laguna Hills, California, United States, 92637
        • Site 235
      • Long Beach, California, United States, 90806
        • Site 215
      • Los Gatos, California, United States, 95032
        • Site 238
      • Napa, California, United States, 94558
        • Site 262
      • Oakland, California, United States, 94607
        • Site 201
      • Sacramento, California, United States, 95831
        • Site 225
      • San Diego, California, United States, 92105
        • Site 231
      • San Diego, California, United States, 92120
        • Site 237
      • Wildomar, California, United States, 92595
        • Site 221
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Site 248
    • Florida
      • Bradenton, Florida, United States, 34205
        • Site 228
      • Clearwater, Florida, United States, 33765
        • Site 214
      • Gainesville, Florida, United States, 32607
        • Site 270
      • Inverness, Florida, United States, 34452
        • Site 269
      • Jupiter, Florida, United States, 33458
        • Site 227
      • Lake Worth, Florida, United States, 33462
        • Site 204
      • Miami Beach, Florida, United States, 33140
        • Site 211
      • Miami Beach, Florida, United States, 33140
        • Site 229
      • Plantation, Florida, United States, 33317
        • Site 278
      • Port Orange, Florida, United States, 32129
        • Site 232
      • Sarasota, Florida, United States, 34232
        • Site 264
      • Winter Park, Florida, United States, 32789
        • Site 271
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Site 223
      • Marietta, Georgia, United States, 30060
        • Site 212
    • Idaho
      • Boise, Idaho, United States, 83713
        • Site 245
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Site 255
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Site 222
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Site 236
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Site 277
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Site 206
      • Shreveport, Louisiana, United States, 71105
        • Site 224
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • Site 249
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Site 226
      • New Bedford, Massachusetts, United States, 02740
        • Site 254
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Site 210
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Site 244
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Site 234
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Site 265
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Site 266
      • Somerset, New Jersey, United States, 08873
        • Site 267
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Site 252
    • New York
      • Kew Gardens, New York, United States, 11415
        • Site 261
      • New York, New York, United States, 10019
        • Site 243
      • Rochester, New York, United States, 14618
        • Site 233
      • Williamsville, New York, United States, 14221
        • Site 208
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • Site 203
      • Winston-Salem, North Carolina, United States, 27103
        • Site 213
      • Winston-Salem, North Carolina, United States, 27103
        • Site 242
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Site 276
      • Franklin, Ohio, United States, 45005
        • Site 209
      • Kettering, Ohio, United States, 45429
        • Site 259
      • Toledo, Ohio, United States, 43623
        • Site 240
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73119
        • Site 239
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site 279
      • Jenkintown, Pennsylvania, United States, 19046
        • Site 256
      • Lansdale, Pennsylvania, United States, 19446
        • Site 258
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Site 205
      • Greenville, South Carolina, United States, 29601
        • Site 247
      • Spartanburg, South Carolina, United States, 29303
        • Site 251
    • Texas
      • Austin, Texas, United States, 78704
        • Site 218
      • Hurst, Texas, United States, 76054
        • Site 263
      • Richardson, Texas, United States, 75080
        • Site 219
      • San Antonio, Texas, United States, 78207
        • Site 275
    • Washington
      • Everett, Washington, United States, 98201
        • Site 241
      • Spokane, Washington, United States, 99202
        • Site 257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxycodone extended-release
Egalet ADER oxycodone tablet
Drug: Oxycodone extended-release
Other Names:
  • Egalet-002, Egalet ADER oxycodone
Placebo Comparator: Placebo of Oxycodone extended-release
Egalet ADER oxycodone placebo tablet
Drug: Placebo of oxycodone extended-release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: daily (past 24 hours) worst pain intensity score (WPI)
Time Frame: 16 Weeks
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
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egalet Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 2, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC-EG-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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