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
1 other identifier
interventional
281
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
Shorter than P25 for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
March 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2017
CompletedMarch 5, 2018
March 1, 2018
1.3 years
November 10, 2015
March 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period
1 year
Study Arms (1)
Oxycodone extended-release
EXPERIMENTALEgalet abuse-deterrent, extended-release oxycodone tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Egalet Ltdlead
Study Sites (39)
Site 334
Huntsville, Alabama, 35801, United States
Site 328
Tucson, Arizona, 85712, United States
Site 332
Jacksonville, Florida, 32257, United States
Site 340
Miami Gardens, Florida, 33169, United States
Site 320
Plantation, Florida, 33317, United States
Site 302
Tampa, Florida, 33603, United States
Site 315
Tampa, Florida, 33613, United States
Site 310
Winter Haven, Florida, 33880, United States
Site 316
Dawsonville, Georgia, 30534, United States
Site 311
Marietta, Georgia, 30060, United States
Site 336
Bloomington, Illinois, 61701, United States
Site 345
Blue Island, Illinois, 60406, United States
Site 304
Evansville, Indiana, 47714, United States
Site 325
Valparaiso, Indiana, 46383, United States
Site 321
Overland Park, Kansas, 66210, United States
Site 342
Wichita, Kansas, 67205, United States
Site 329
New Orleans, Louisiana, 70114, United States
Site 326
Quincy, Massachusetts, 02169, United States
Site 303
St Louis, Missouri, 63141, United States
Site 306
Las Vegas, Nevada, 89119, United States
Site 313
Belvidere, New Jersey, 07823, United States
Site 346
Blackwood, New Jersey, 08012, United States
Site 323
Hartsdale, New York, 10530, United States
Site 338
Mooresville, North Carolina, 28117, United States
Site 333
Cincinnati, Ohio, 45212, United States
Site 343
Cleveland, Ohio, 44122, United States
Site 308
Huber Heights, Ohio, 45424, United States
Site 347
Kettering, Ohio, 45429, United States
Site 335
Oklahoma City, Oklahoma, 73112, United States
Site 312
Eugene, Oregon, 97401, United States
Site 322
Duncansville, Pennsylvania, 16635, United States
Site 324
Wyomissing, Pennsylvania, 19610, United States
Site 344
Myrtle Beach, South Carolina, 29588, United States
Site 314
Summerville, South Carolina, 29485, United States
Site 341
New Tazewell, Tennessee, 37825, United States
Site 318
Austin, Texas, 78731, United States
Site 330
Dallas, Texas, 75231, United States
Site 309
San Antonio, Texas, 78218, United States
Site 331
West Jordan, Utah, 84088, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 13, 2015
Study Start
March 7, 2016
Primary Completion
June 15, 2017
Study Completion
June 15, 2017
Last Updated
March 5, 2018
Record last verified: 2018-03