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The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Twice Daily Dosing |
|
| Buprenorphine HCl Buccal Film | Experimental | Twice Daily Dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Average Daily Pain Intensity Scores | Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response to Treatment (Responder) Using NRS Scale | Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable). | Prior to open-label titration to Week 12 in double-blind treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Todd Kirby, PhD | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Horizon Research Group, Inc./Alabama Orthopedic Clinic | Mobile | Alabama | 36608 | United States | ||
| Arizona Research Center |
Of 1633 subjects screened, a total of 752 subjects were enrolled into the open-label (OL) titration phase. Subjects who completed the OL titration phase (462) were eligible for randomization in the double-blind (DB) treatment phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | OL Buprenorphine HCl Buccal Film | Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase |
| FG001 | DB Buprenorphine HCl Buccal Film |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Titration Phase |
|
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| Placebo | Drug | Matching Placebo Buccal Film twice daily |
|
|
| Number of Subjects With Rescue Medication Use | Use of analgesic rescue medication recorded in subject diary. | Week 1 to Week 12 in double-blind treatment |
| Time to Optimal Dose of Open-label Study Medication | Overall time to reach the "optimal" dose of study medication required to progress to double-blind treatment. | Up to 8 weeks in open-label titration |
| Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) | Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase. | Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks) |
| Patient Global Impression of Change | Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference) | Week 12 |
| Change From Baseline to Week 12 in Roland Morris Disability Questionnaire | Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability. | Baseline, Week 12 |
| Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale | Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep). | Baseline, Week 12 |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Global Research | Anaheim | California | 92804 | United States |
| Catalina Research Institute, LLC | Chino | California | 91710 | United States |
| Synergy Clinical Research Center of Escondido | Escondido | California | 92025 | United States |
| Adam D. Karns MD | Los Angeles | California | 90036 | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | 06905 | United States |
| Clinical Research of West Florida - Clearwater | Clearwater | Florida | 33765 | United States |
| Century Clinical Research, Inc. | Daytona Beach | Florida | 32117 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Florida Health Center | Fort Lauderdale | Florida | 33312 | United States |
| Eastern Research, Inc. | Hialeah | Florida | 33013 | United States |
| Florida Institute of Medical Research | Jacksonville | Florida | 32257 | United States |
| Drug Study Institute | Jupiter | Florida | 33458 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| NEMA Research, Inc. | Naples | Florida | 34108 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Peninsula Research | Ormond Beach | Florida | 32174 | United States |
| Gold Coast Research, L.L.C. | Plantation | Florida | 33317 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Clinical Research of West Florida - Tampa | Tampa | Florida | 33603 | United States |
| National Pain Research Institute, LLC | Winter Park | Florida | 32789 | United States |
| Atlanta Research Center | Atlanta | Georgia | 30319 | United States |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| Georgia Institute for Clinical Research, LLC | Marietta | Georgia | 30060 | United States |
| Taylor Research, LLC | Marietta | Georgia | 30060 | United States |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | United States |
| International Clinical Research Institute, Inc. | Overland Park | Kansas | 66210 | United States |
| Willis-Kinghton Physician Network/River Interventional Pain Specialist | Bossier City | Louisiana | 71111 | United States |
| Clinical Trials Management, LLC | Metairie | Louisiana | 70006 | United States |
| Best Clinical Trials, Inc. | New Orleans | Louisiana | 70115 | United States |
| River Cities Clinical Research Center | Shreveport | Louisiana | 71105 | United States |
| MedVadis Research Corp. | Watertown | Massachusetts | 02472 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| The Center for Clinical Trials | Biloxi | Mississippi | 39531 | United States |
| Office of Robert Kaplan, DO | Las Vegas | Nevada | 89119 | United States |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | United States |
| Upstate Clinical Research Associates LLC | Williamsville | New York | 14221 | United States |
| PharmQuest, LLC | Greensboro | North Carolina | 27408 | United States |
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Plains Medical Clinic, LLC | Fargo | North Dakota | 58104 | United States |
| Clinical Inquest Center, Ltd. | Beavercreek | Ohio | 45432 | United States |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | United States |
| Optimed Research, Ltd. | Columbus | Ohio | 43235 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | United States |
| NPC Research | Oklahoma City | Oklahoma | 73109 | United States |
| Brandywine Clinical Research | Downingtown | Pennsylvania | 19335 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| FutureSearch Clinical Trials - Austin | Austin | Texas | 78731 | United States |
| KRK Medical Research | Dallas | Texas | 75230 | United States |
| FutureSearch Trials of Dallas, LP | Dallas | Texas | 75231 | United States |
| Advanced Clinical Research of Houston | Houston | Texas | 77062 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| Innovative Clinical Trials | San Antonio | Texas | 78229 | United States |
| Highland Clinical Research | Salt Lake City | Utah | 84124 | United States |
| Clinical Investigations Specialists, Inc. | Kenosha | Wisconsin | 53142 | United States |
Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase |
| FG002 | DB Placebo Film | Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Treatment Phase |
|
|
Analysis based on intent-to-treat (ITT) population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.
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| ID | Title | Description |
|---|---|---|
| BG000 | DB Buprenorphine HCl Buccal Film | Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase |
| BG001 | DB Placebo Film | Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 12 in Average Daily Pain Intensity Scores | Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable). | Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Response to Treatment (Responder) Using NRS Scale | Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable). | Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population. | Posted | Number | participants | Prior to open-label titration to Week 12 in double-blind treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Rescue Medication Use | Use of analgesic rescue medication recorded in subject diary. | Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population. | Posted | Number | participants | Week 1 to Week 12 in double-blind treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Optimal Dose of Open-label Study Medication | Overall time to reach the "optimal" dose of study medication required to progress to double-blind treatment. | Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment. | Posted | Mean | Standard Deviation | days | Up to 8 weeks in open-label titration |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks) | Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase. | Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population. | Posted | Number | percentage of participants | Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change | Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference) | Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (41). Includes only participants with PGIC assessment at week 12 (n=198 buprenorphine and n=194 placebo). | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Roland Morris Disability Questionnaire | Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability. | Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with RMDQ assessment at week 12 (n=193 buprenorphine and n=189 placebo). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale | Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep). | Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with MOS assessment at week 12 (n=199 buprenorphine and n=194 placebo). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
From informed consent at screening through 14 days after last dose in the double-blind treatment phase (up to 24 weeks)
Analysis based on Safety population; all enrolled subjects who received at least 1 dose of study drug in the respective period (open-label titration and double-blind treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OL Buprenorphine HCl Buccal Film | Buprenorphine HCl buccal film, 75, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration treatment phase | 4 | 749 | 443 | 749 | ||
| EG001 | DB Buprenorphine HCl Buccal Film | Buprenorphine HCl buccal film, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase | 3 | 229 | 43 | 229 | ||
| EG002 | DB Placebo Film | Placebo buccal film, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase | 1 | 232 | 31 | 232 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dry gangrene | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
|
PI and Institution reserve the right to publish and present the results of the work performed provided that Institution and/or PI submits a copy of any proposed publication to Sponsor's agent for review and comment at least 90 days in advance of its presentation or submission for publication. In addition, if Sponsor's agent requests, Institution and/or PI will withhold publication or presentation for an additional 60 days to allow for establishing and preserving its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals Inc. | clinicalsite.inquiries@endo.com |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
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| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal due to opioid withdrawal |
|
| Not exposed to DB study medication |
|
| Other |
|
| >=65 years |
|
| Male |
|
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| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|