Trial record 1 of 1 for:
oc-eg-303
Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02603705 |
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Recruitment Status :
Completed
First Posted : November 13, 2015
Last Update Posted : March 5, 2018
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Sponsor:
Egalet Ltd
Information provided by (Responsible Party):
Egalet Ltd
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Moderate-to-severe Chronic Noncancer Pain | Drug: Oxycodone extended-release | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 281 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | March 7, 2016 |
| Actual Primary Completion Date : | June 15, 2017 |
| Actual Study Completion Date : | June 15, 2017 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Oxycodone extended-release
Egalet abuse-deterrent, extended-release oxycodone tablet
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Drug: Oxycodone extended-release |
Primary Outcome Measures :
- 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 [ Time Frame: 1 year ]
Secondary Outcome Measures :
- Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period [ Time Frame: 1 year ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603705
Hide Study Locations
Locations
| United States, Alabama | |
| Site 334 | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Site 328 | |
| Tucson, Arizona, United States, 85712 | |
| United States, Florida | |
| Site 332 | |
| Jacksonville, Florida, United States, 32257 | |
| Site 340 | |
| Miami Gardens, Florida, United States, 33169 | |
| Site 320 | |
| Plantation, Florida, United States, 33317 | |
| Site 302 | |
| Tampa, Florida, United States, 33603 | |
| Site 315 | |
| Tampa, Florida, United States, 33613 | |
| Site 310 | |
| Winter Haven, Florida, United States, 33880 | |
| United States, Georgia | |
| Site 316 | |
| Dawsonville, Georgia, United States, 30534 | |
| Site 311 | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Site 336 | |
| Bloomington, Illinois, United States, 61701 | |
| Site 345 | |
| Blue Island, Illinois, United States, 60406 | |
| United States, Indiana | |
| Site 304 | |
| Evansville, Indiana, United States, 47714 | |
| Site 325 | |
| Valparaiso, Indiana, United States, 46383 | |
| United States, Kansas | |
| Site 321 | |
| Overland Park, Kansas, United States, 66210 | |
| Site 342 | |
| Wichita, Kansas, United States, 67205 | |
| United States, Louisiana | |
| Site 329 | |
| New Orleans, Louisiana, United States, 70114 | |
| United States, Massachusetts | |
| Site 326 | |
| Quincy, Massachusetts, United States, 02169 | |
| United States, Missouri | |
| Site 303 | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, Nevada | |
| Site 306 | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New Jersey | |
| Site 313 | |
| Belvidere, New Jersey, United States, 07823 | |
| Site 346 | |
| Blackwood, New Jersey, United States, 08012 | |
| United States, New York | |
| Site 323 | |
| Hartsdale, New York, United States, 10530 | |
| United States, North Carolina | |
| Site 338 | |
| Mooresville, North Carolina, United States, 28117 | |
| United States, Ohio | |
| Site 333 | |
| Cincinnati, Ohio, United States, 45212 | |
| Site 343 | |
| Cleveland, Ohio, United States, 44122 | |
| Site 308 | |
| Huber Heights, Ohio, United States, 45424 | |
| Site 347 | |
| Kettering, Ohio, United States, 45429 | |
| United States, Oklahoma | |
| Site 335 | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Site 312 | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Site 322 | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Site 324 | |
| Wyomissing, Pennsylvania, United States, 19610 | |
| United States, South Carolina | |
| Site 344 | |
| Myrtle Beach, South Carolina, United States, 29588 | |
| Site 314 | |
| Summerville, South Carolina, United States, 29485 | |
| United States, Tennessee | |
| Site 341 | |
| New Tazewell, Tennessee, United States, 37825 | |
| United States, Texas | |
| Site 318 | |
| Austin, Texas, United States, 78731 | |
| Site 330 | |
| Dallas, Texas, United States, 75231 | |
| Site 309 | |
| San Antonio, Texas, United States, 78218 | |
| United States, Utah | |
| Site 331 | |
| West Jordan, Utah, United States, 84088 | |
Sponsors and Collaborators
Egalet Ltd
| Responsible Party: | Egalet Ltd |
| ClinicalTrials.gov Identifier: | NCT02603705 History of Changes |
| Other Study ID Numbers: |
OC-EG-303 |
| First Posted: | November 13, 2015 Key Record Dates |
| Last Update Posted: | March 5, 2018 |
| Last Verified: | March 2018 |
Keywords provided by Egalet Ltd:
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chronic pain opioid oxycodone non cancer pain moderate to severe |
Additional relevant MeSH terms:
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Oxycodone Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |