Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain

An Open-label Phase 3 Trial to Evaluate the Safety and Tolerability of Egalet ADER Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Noncancer Pain

The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in opioid-experienced patients with moderate-to-severe chronic noncancer pain.

Study Overview

• Status: Completed
• Conditions: Moderate-to-severe Chronic Noncancer Pain
• Intervention / Treatment: Drug: Oxycodone extended-release

• Study Type: Interventional
• Enrollment (Actual): 281
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Site 334
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Site 328
  • Florida
    • Jacksonville, Florida, United States, 32257
      • Site 332
    • Miami Gardens, Florida, United States, 33169
      • Site 340
    • Plantation, Florida, United States, 33317
      • Site 320
    • Tampa, Florida, United States, 33603
      • Site 302
    • Tampa, Florida, United States, 33613
      • Site 315
    • Winter Haven, Florida, United States, 33880
      • Site 310
  • Georgia
    • Dawsonville, Georgia, United States, 30534
      • Site 316
    • Marietta, Georgia, United States, 30060
      • Site 311
  • Illinois
    • Bloomington, Illinois, United States, 61701
      • Site 336
    • Blue Island, Illinois, United States, 60406
      • Site 345
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Site 304
    • Valparaiso, Indiana, United States, 46383
      • Site 325
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Site 321
    • Wichita, Kansas, United States, 67205
      • Site 342
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Site 329
  • Massachusetts
    • Quincy, Massachusetts, United States, 02169
      • Site 326
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Site 303
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Site 306
  • New Jersey
    • Belvidere, New Jersey, United States, 07823
      • Site 313
    • Blackwood, New Jersey, United States, 08012
      • Site 346
  • New York
    • Hartsdale, New York, United States, 10530
      • Site 323
  • North Carolina
    • Mooresville, North Carolina, United States, 28117
      • Site 338
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Site 333
    • Cleveland, Ohio, United States, 44122
      • Site 343
    • Huber Heights, Ohio, United States, 45424
      • Site 308
    • Kettering, Ohio, United States, 45429
      • Site 347
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Site 335
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Site 312
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Site 322
    • Wyomissing, Pennsylvania, United States, 19610
      • Site 324
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29588
      • Site 344
    • Summerville, South Carolina, United States, 29485
      • Site 314
  • Tennessee
    • New Tazewell, Tennessee, United States, 37825
      • Site 341
  • Texas
    • Austin, Texas, United States, 78731
      • Site 318
    • Dallas, Texas, United States, 75231
      • Site 330
    • San Antonio, Texas, United States, 78218
      • Site 309
  • Utah
    • West Jordan, Utah, United States, 84088
      • Site 331

Participation Criteria

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 a man or woman between 18 and 75 years of age.
• Has a clinical history of moderate-to-severe chronic noncancer pain ≥6 months.
• Has required opioid therapy for at least 14 days prior to Screening at a dose between 20 mg and 160 mg (inclusive) oxycodone/day (or opioid equivalent), and will, in the opinion of the investigator, continue to require opioid therapy (between 20 mg and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe pain for the duration of the study.
• Has pain either not adequately controlled on current opioid regimen, requires a change of opioid due to tolerability of current opioid regimen or in the opinion of the investigator, would benefit from changing opioid for another reason.
• 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 through the duration of the study), or is of non-childbearing potential.
• Other Criteria Apply

Exclusion Criteria:

• Has cancer-related pain.
• Is receiving >240 mg oxycodone daily (or opioid equivalent) within 30 days before Screening.
• Has a history of attempted suicide.
• Has used a spinal infusion pump within 6 months before Screening.
• Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) and/or respiratory disease (including chronic obstructive pulmonary disease or sleep apnea).
• Has positive urine toxicity screen for drugs of abuse (with the exception of prescribed medications).
• Has positive result for tetrahydrocannabinol (even if legally prescribed).
• Has current (or history of within the last 12 months) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
• Other Criteria Apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxycodone extended-release; Egalet abuse-deterrent, extended-release oxycodone tablet	Drug: Oxycodone extended-release

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of TEAEs during the Open-label Treatment Period, including those leading to treatment withdrawal, and/or abnormal physical examination findings, vital signs measurements, ECGs, and clinical laboratory test results, related to treatment	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period	1 year

Collaborators and Investigators

• Sponsor: Egalet Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2016
• Primary Completion (Actual): June 15, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 13, 2015

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

• Keywords: chronic pain; opioid; oxycodone; moderate to severe; non cancer pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: OC-EG-303