Moderate-to-severe Chronic Noncancer PainPhase 3NCT02603705
Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain
A Phase 3 study testing Oxycodone extended-release in people with Moderate-to-severe Chronic Noncancer Pain, run by Egalet Ltd at 39 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate-to-severe Chronic Noncancer Pain
- What is being tested?
- Oxycodone extended-release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 39 sitesUnited States
- Study dates
- 7 Mar 2016to 15 Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Site 318
Austin, Texas, 78731
Site 313
Belvidere, New Jersey, 07823
Site 346
Blackwood, New Jersey, 08012
Site 336
Bloomington, Illinois, 61701
Site 345
Blue Island, Illinois, 60406
Site 333
Cincinnati, Ohio, 45212
Site 343
Cleveland, Ohio, 44122
Site 330
Dallas, Texas, 75231
Site 316
Dawsonville, Georgia, 30534
Site 322
Duncansville, Pennsylvania, 16635
Site 312
Eugene, Oregon, 97401
Site 304
Evansville, Indiana, 47714
Site 323
Hartsdale, New York, 10530
Site 308
Huber Heights, Ohio, 45424
Site 334
Huntsville, Alabama, 35801
Site 332
Jacksonville, Florida, 32257
Site 347
Kettering, Ohio, 45429
Site 306
Las Vegas, Nevada, 89119
Site 311
Marietta, Georgia, 30060
Site 340
Miami Gardens, Florida, 33169
Site 338
Mooresville, North Carolina, 28117
Site 344
Myrtle Beach, South Carolina, 29588
Site 329
New Orleans, Louisiana, 70114
Site 341
New Tazewell, Tennessee, 37825
Site 335
Oklahoma City, Oklahoma, 73112
Site 321
Overland Park, Kansas, 66210
Site 320
Plantation, Florida, 33317
Site 326
Quincy, Massachusetts, 02169
Site 309
San Antonio, Texas, 78218
Site 303
St Louis, Missouri, 63141
Site 314
Summerville, South Carolina, 29485
Site 302
Tampa, Florida, 33603
Site 315
Tampa, Florida, 33613
Site 328
Tucson, Arizona, 85712
Site 325
Valparaiso, Indiana, 46383
Site 331
West Jordan, Utah, 84088
Site 342
Wichita, Kansas, 67205
Site 310
Winter Haven, Florida, 33880
Site 324
Wyomissing, Pennsylvania, 19610
About this study
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
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.
- Being tested
- Oxycodone extended-release
- Keywords
- chronic pain, opioid, oxycodone, non cancer pain, moderate to severe
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone extended-releaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone extended-release | Experimental | Egalet abuse-deterrent, extended-release oxycodone tablet Receives: Drug: Oxycodone extended-release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start7 Mar 2016
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Chronic Noncancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603705
- Sponsor's protocol ID
- OC-EG-303
- Status last verified
- Mar 2018
- First submitted
- 10 Nov 2015
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02603705
- Acronym / sponsor ID
- OC-EG-303
- Keywords
- chronic pain, opioid, oxycodone, non cancer pain, moderate to severe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxycodone extended-release | Experimental | Drug: Oxycodone extended-releaseEgalet abuse-deterrent, extended-release oxycodone tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone extended-release | Drug | Oxycodone extended-release |
Primary outcome
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
1 secondary outcome
Findings of the Brief Pain Inventory-Short Form (BPI-SF) during the Open-label Treatment Period
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxycodone extended-release in people with Moderate-to-severe Chronic Noncancer Pain, run by Egalet Ltd at 39 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.