Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Buprenorphine transdermal system 10 and 20 applied for 7-day wear |
|
| 2 | Placebo Comparator | Placebo transdermal system to match BTDS patches, applied for 7-day wear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | transdermal system 10 and 20 applied for 7-day wear |
| |
| Measure | Description | Time Frame |
|---|---|---|
| "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. | "Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily. | 24 hours (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase. | Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen). | 10 weeks |
| Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research, Inc. | Mobile | Alabama | 36608 | United States | ||
| Radiant Research, Phoenix Southeast |
Open-label run-in period designed to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). N = 1151 entered the run-in period, and N = 571 completed. One subject was not dosed, therefore N = 570 randomized. N = 3 subjects did not have safety data, therefore N = 567 had double-blind data.
27-Sep-2007 (first patient first visit) to 28-Apr-2009 (last patient last visit) at 83 medical/research sites in US
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind BTDS 10 or 20 | Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear |
| FG001 | Double-blind Placebo | Placebo patches to match the BTDS patches applied for 7-day wear |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
transdermal system (placebo) applied for 7-day wear |
|
The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance. |
| Weeks 4, 8, and 12 of the double-bind phase |
| Chandler |
| Arizona |
| 85225 |
| United States |
| Arizona Research Center, Inc. | Phoenix | Arizona | 85023 | United States |
| Research Facility | Phoenix | Arizona | 85029 | United States |
| Research Facility | Phoenix | Arizona | 85032 | United States |
| Research Facility | Anaheim | California | 92801 | United States |
| Lovelace Scientific Resources, Inc. | Beverly Hills | California | 90211 | United States |
| Catalina Research Institute | Chino | California | 91710 | United States |
| Research Facility | Downey | California | 90241 | United States |
| Research Facility | Foothill Ranch | California | 92610 | United States |
| Research Facility | Laguna Hills | California | 92653 | United States |
| Research Facility | Sacramento | California | 95831 | United States |
| Research Facility | Littleton | Colorado | 80128 | United States |
| Research Facility | Stamford | Connecticut | 06905 | United States |
| Coastal Pain Management | Bradenton | Florida | 34209 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Research Facility | Clearwater | Florida | 33765 | United States |
| Research Facility | Jupiter | Florida | 33458-7200 | United States |
| Research Facility | Largo | Florida | 33765 | United States |
| Pharmax Research Clinic | Miami | Florida | 33126 | United States |
| Research Facility | Miami | Florida | 33135 | United States |
| Research Facility | Orlando | Florida | 32806 | United States |
| Research Facility | Plantation | Florida | 33324 | United States |
| Research Facility | Royal Palm Hammock | Florida | 33411 | United States |
| Clinical Research of West Flor | Tampa | Florida | 33603 | United States |
| Research Facility | Tampa | Florida | 33613 | United States |
| Research Facility | Venice | Florida | 34292 | United States |
| Research Facility | West Palm Beach | Florida | 33409 | United States |
| Research Facility | Atlanta | Georgia | 30342 | United States |
| Research Facility | Augusta | Georgia | 30901 | United States |
| AMR Research Associates | Bogart | Georgia | 30622-6821 | United States |
| Research Facility | Dawsonville | Georgia | 30534 | United States |
| Research Facility | Decatur | Georgia | 30033 | United States |
| Research Facility | Marietta | Georgia | 30066 | United States |
| Research Facility | Honolulu | Hawaii | 96814-4526 | United States |
| Rehabilitation Association of IN | Indianapolis | Indiana | 46250 | United States |
| Research Facility | Overland Park | Kansas | 66211 | United States |
| Graves-Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Stat-Lab I, Inc. | Baton Rouge | Louisiana | 70808 | United States |
| Research Facility | New Iberia | Louisiana | 70563 | United States |
| Research Facility | New Orleans | Louisiana | 70114 | United States |
| Research Facility | Frederick | Maryland | 21702 | United States |
| Research Facility | Brockton | Massachusetts | 02301 | United States |
| East Coast Clinical Research | Haverhill | Massachusetts | 01830-6141 | United States |
| Research Facility | Springfield | Massachusetts | 01103 | United States |
| Research Facility | Bay City | Michigan | 48706 | United States |
| Premier Internal Medicine | Biloxi | Mississippi | 39531 | United States |
| Research Facility | Florissant | Missouri | 63031 | United States |
| Research Facility | St Louis | Missouri | 63117 | United States |
| Sports Med Consultants PC | St Louis | Missouri | 63141 | United States |
| Research Facility | Henderson | Nevada | 89014 | United States |
| Research Facility | New York | New York | 10004 | United States |
| Research Facility | New York | New York | 10022 | United States |
| Research Facility | Morgantown | North Carolina | 28655 | United States |
| Research Facility | Winston-Salem | North Carolina | 27103 | United States |
| Research Facility | Canton | Ohio | 44718 | United States |
| Research Facility | Cincinnati | Ohio | 45242 | United States |
| Research Facility | Columbus | Ohio | 43213 | United States |
| Research Facility | Columbus | Ohio | 43235 | United States |
| Digestive Endoscopy Center | Dayton | Ohio | 45415 | United States |
| Research Facility | Dayton | Ohio | 45432 | United States |
| Research Facility | Middleburg Heights | Ohio | 44130 | United States |
| Research Facility | Mount Gilead | Ohio | 43338 | United States |
| Research Facility | Toledo | Ohio | 43623 | United States |
| Research Facility | Oklahoma City | Oklahoma | 73109 | United States |
| Research Facility | Eugene | Oregon | 97404 | United States |
| Research Facility | Medford | Oregon | 97504-8311 | United States |
| Paramount Clinical Research | Bridgeville | Pennsylvania | 15017 | United States |
| Research Facility | Duncansville | Pennsylvania | 16635 | United States |
| Oyster Point Family Health Ctr | Lancaster | Pennsylvania | 17601 | United States |
| Research Facility | Mechanicsburg | Pennsylvania | 17055 | United States |
| Research Facility | West Reading | Pennsylvania | 19611 | United States |
| New England Center for Clinical Research | Cranston | Rhode Island | 02920 | United States |
| Research Facility | Cranston | Rhode Island | 02920 | United States |
| Greenville Pharmaceutical Research | Greenville | South Carolina | 29415 | United States |
| Arthritis Clinic, PLLC | Jackson | Tennessee | 38305 | United States |
| Research Facility | Austin | Texas | 78756 | United States |
| Research Facility | Colleyville | Texas | 76034 | United States |
| Research Facility | Dallas | Texas | 75230 | United States |
| Research Facility | Nederland | Texas | 77627 | United States |
| Research Facility | San Antonio | Texas | 78205-1116 | United States |
| Research Facility | San Antonio | Texas | 78229 | United States |
| Research Facility | Sugarland | Texas | 77479 | United States |
| Research Facility | Salt Lake City | Utah | 84102 | United States |
| NDC Medical Center | Norfolk | Virginia | 23502 | United States |
| Independence Family Medicine | Virginia Beach | Virginia | 23455 | United States |
| Pacific Northwest Primary Care | Tacoma | Washington | 98405 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind BTDS 10 or 20 | Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear |
| BG001 | Double-blind Placebo | Placebo patches to match the BTDS patches applied for 7-day wear |
| 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 Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. | "Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily. | The full analysis population is the group of subjects who were randomized and received at least 1 dose of double-blind study drug | Posted | Mean | Standard Deviation | units on a scale | 24 hours (week 12) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase. | Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen). | Subjects in the full analysis population who took at least 1 dose of supplemental analgesic medication. | Posted | Mean | Standard Deviation | tablets | 10 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase. | The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance. | Full Analysis Population (N = 570) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | Posted | Mean | Standard Deviation | units on a scale | Weeks 4, 8, and 12 of the double-bind phase |
|
|
Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after discontinuation; or Serious AEs occurring up to 30 days following the last study visit were followed until resolution or for up to 30 days.
AEs were obtained through spontaneous reports and subject interview.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-blind BTDS | Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear | 13 | 282 | 108 | 282 | ||
| EG001 | Double-blind Placebo | Placebo patches to match the BTDS patches applied for 7-day wear | 3 | 285 | 53 | 285 | ||
| EG002 | Open-label Run-in Period | The open-label run-in period was designed with duration of time sufficient to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). During this period, subjects were required to discontinue use of all nonstudy drugs used for the treatment of chronic pain and no supplemental analgesic medications were allowed. Subjects who did not tolerate BTDS 5 were discontinued from the study. | 5 | 1,151 | 520 | 1,151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery - DEATH | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | DEATH Systematic and nonsystematic assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment One subject experienced bradycardia poststudy |
|
| Coronary artery disease | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Hypertensive heart disease - DEATH | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | DEATH Systematic and nonsystematic assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Chest pain | General disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Noncardiac chest pain | General disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Cardiac procedure complications | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Collapse of lung | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Blood pressure increased | Investigations | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Syncope | Nervous system disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessments One subject experienced acute myocardial infarction poststudy |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA (9.1) | Systematic Assessment | Poststudy SAE |
|
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment | Poststudy SAE |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment | Poststudy SAE |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment | Poststudy SAE |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Application site pruritus | General disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Application site erythema | General disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Application site rash | General disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Fatigue | General disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Somnolence | Nervous system disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader, Executive Medical Director | Purdue Pharma | 800-733-1333 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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
Not provided
| Male |
|
| Double-blind Week 12 (Visit 8) |
|
|
|
| Participants |
|
|
|