Moderate-to-severe Chronic Low Back PainPhase 3NCT02716857
Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain
A Phase 3 study testing Oxycodone extended-release in people with Moderate-to-severe Chronic Low Back Pain, run by Egalet Ltd at 74 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate-to-severe Chronic Low Back Pain
- What is being tested?
- Oxycodone extended-release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 549 participants
- Where
- 74 sitesUnited States
- Study dates
- Mar 2016to Nov 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 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
Who cannot join
- 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.
Trial locations and contacts
74 sites in 1 country.
74 sites in 1 country
United States74 sites
Site 252
Albuquerque, New Mexico, 87102
Site 217
Anaheim, California, 92801
Site 280
Anaheim, California, 92804
Site 223
Atlanta, Georgia, 30309
Site 218
Austin, Texas, 78704
Site 210
Bay City, Michigan, 48706
Site 207
Birmingham, Alabama, 35209
Site 245
Boise, Idaho, 83713
Site 226
Boston, Massachusetts, 02135
Site 248
Boulder, Colorado, 80301
Site 228
Bradenton, Florida, 34205
Site 205
Charleston, South Carolina, 29406
Site 203
Charlotte, North Carolina, 28209
Site 255
Chicago, Illinois, 60614
Site 214
Clearwater, Florida, 33765
Site 276
Columbus, Ohio, 43210
Site 279
Duncansville, Pennsylvania, 16635
Site 222
Evansville, Indiana, 47714
Site 241
Everett, Washington, 98201
Site 209
Franklin, Ohio, 45005
Site 270
Gainesville, Florida, 32607
Site 247
Greenville, South Carolina, 29601
Site 234
Hazelwood, Missouri, 63042
Site 263
Hurst, Texas, 76054
Site 269
Inverness, Florida, 34452
Site 244
Jackson, Mississippi, 39202
Site 256
Jenkintown, Pennsylvania, 19046
Site 227
Jupiter, Florida, 33458
Site 259
Kettering, Ohio, 45429
Site 261
Kew Gardens, New York, 11415
Site 220
La Mesa, California, 91942
Site 235
Laguna Hills, California, 92637
SIte 204
Lake Worth, Florida, 33462
Site 258
Lansdale, Pennsylvania, 19446
Site 215
Long Beach, California, 90806
Site 238
Los Gatos, California, 95032
Site 212
Marietta, Georgia, 30060
Site 211
Miami Beach, Florida, 33140
Site 229
Miami Beach, Florida, 33140
Site 202
Mobile, Alabama, 36608
Site 262
Napa, California, 94558
Site 254
New Bedford, Massachusetts, 02740
Site 206
New Orleans, Louisiana, 70115
Site 243
New York, New York, 10019
Site 201
Oakland, California, 94607
Site 239
Oklahoma City, Oklahoma, 73119
Site 265
Omaha, Nebraska, 68114
Site 277
Overland Park, Kansas, 66210
Site 253
Phoenix, Arizona, 85018
Site 260
Phoenix, Arizona, 85018
Site 268
Phoenix, Arizona, 85029
Site 249
Pikesville, Maryland, 21208
Site 278
Plantation, Florida, 33317
Site 232
Port Orange, Florida, 32129
Site 266
Princeton, New Jersey, 08540
Site 219
Richardson, Texas, 75080
Site 233
Rochester, New York, 14618
Site 225
Sacramento, California, 95831
Site 275
San Antonio, Texas, 78207
Site 231
San Diego, California, 92105
Site 237
San Diego, California, 92120
Site 264
Sarasota, Florida, 34232
Site 224
Shreveport, Louisiana, 71105
Site 267
Somerset, New Jersey, 08873
Site 251
Spartanburg, South Carolina, 29303
Site 257
Spokane, Washington, 99202
Site 240
Toledo, Ohio, 43623
Site 282
Tucson, Arizona, 85704
SIte 236
West Des Moines, Iowa, 50265
Site 221
Wildomar, California, 92595
Site 208
Williamsville, New York, 14221
Site 213
Winston-Salem, North Carolina, 27103
Site 242
Winston-Salem, North Carolina, 27103
Site 271
Winter Park, Florida, 32789
About this study
Official title: 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
- Conditions
- Moderate-to-severe Chronic Low Back Pain
- Being tested
- Oxycodone extended-release, Placebo of oxycodone extended-release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone extended-releaseDrug
Also called Egalet-002, Egalet ADER oxycodone
Placebo of oxycodone extended-releaseDrug
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone extended-release | Experimental | Egalet ADER oxycodone tablet Receives: Drug: Oxycodone extended-release |
| Placebo of Oxycodone extended-release | Placebo comparator | Egalet ADER oxycodone placebo tablet Receives: Drug: Placebo of oxycodone extended-release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Average Pain Intensity past 24 hours, as measured by a 0-10 NPRS using eDiary collection daily at bedtime.
Measured: 16 weeks
Secondary outcomes (2)
Efficacy: daily (past 24 hours) worst pain intensity score (WPI)
Measured: 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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2017
- Study completionNov 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 Low Back 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 549 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
- NCT02716857
- Sponsor's protocol ID
- OC-EG-302
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2016
- 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
- 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
- ClinicalTrials.gov ID
- NCT02716857
- Acronym / sponsor ID
- OC-EG-302
- Conditions
- Moderate-to-severe Chronic Low Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Mar 2016 (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 determine the analgesic efficacy of Egalet-002 twice daily (BID) in patients with moderate-to-severe chronic low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone extended-release | Experimental | Drug: Oxycodone extended-releaseEgalet ADER oxycodone tablet |
| Placebo of Oxycodone extended-release | Placebo comparator | Drug: Placebo of oxycodone extended-releaseEgalet ADER oxycodone placebo tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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-releaseAlso: Egalet-002, Egalet ADER oxycodone | Drug | Oxycodone extended-release |
| Placebo of oxycodone extended-release | Drug | Placebo of Oxycodone extended-release |
Primary outcome
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
2 secondary outcomes
Efficacy: daily (past 24 hours) worst pain intensity score (WPI)
Time frame: 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
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.
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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.
74 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 Low Back Pain, run by Egalet Ltd at 74 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 5 inclusion and 8 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 74 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. Some participants in this study may receive a placebo. 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?
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). 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.