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terminated early for administrative reasons unrelated to safety or efficacy
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The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTDS 5 | Active Comparator | Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear |
|
| BTDS 20 | Experimental | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
|
| Oxycodone Immediate-Release (Oxy IR) 40 mg | Experimental | Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| "Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase. | The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12). | Weeks 4, 8, and 12 of the double-blind phase |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Daily Number of Supplemental Analgesic Medication Tablets | The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®. | Double-blind phase (84 days) |
| The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | United States | ||
| International Clinical Research Network |
Men and women aged 40 years or older with OA of the hip, knee, or spine, on 30 to 80 mg/day morphine sulfate (MSO4) or equivalent, with or without nonopioid analgesic medication. (652 subjects entered the run-in period; 418 completed.) Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
Study Dates: 02-Apr-2004 (first subject first visit) to 18 Jul-2005 (last subject last visit); 15-Jun-2005 (first site notified of study termination). The study took place in 82 medical/research sites in the US; 59 sites randomized at least 1 subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | Run-in Period | The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period. |
| FG001 | Double-blind BTDS 5 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label Run-in Period |
|
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| Buprenorphine | Drug | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
|
|
| oxycodone immediate-release | Drug | Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). |
|
The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete. The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst). |
| Weeks 4, 8 and 12 of the double-blind phase |
| The Sleep Disturbance Subscale in The Medical Outcomes (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 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 and Questions 2 to 12 are scored on a scale of 1 to 6. 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-blind Phase |
| Chula Vista |
| California |
| 91910 |
| United States |
| Clinical Trials Research | Roseville | California | 95661 | United States |
| Accelovance | San Diego | California | 92108 | United States |
| Torrance Clinical Research | Torrance | California | 90505 | United States |
| Southern Colorado Clinic | Pueblo | Colorado | 81008 | United States |
| Drug Study Institute | Jupiter | Florida | 33458 | United States |
| Innovative Research of West Florida, Inc. | Largo | Florida | 33770 | United States |
| International Medical Research | Ormond Beach | Florida | 32174 | United States |
| Peninsula Research, Inc. | Ormond Beach | Florida | 32174 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Georgia Medical Research Institute | Marietta | Georgia | 30060 | United States |
| Non- Surgical Orthopedic & Spine Center, P.C. | Marietta | Georgia | 30060 | United States |
| The Arthritis Center | Springfield | Illinois | 62704 | United States |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | United States |
| Miray Medical Center | Brockton | Massachusetts | 23010 | United States |
| Professional Clinical Research Crystal Lake Health Center | Benzonia | Michigan | 49616 | United States |
| Rheumatology PC | Kalamazoo | Michigan | 49009 | United States |
| Pharm Quest | Greensboro | North Carolina | 27401 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Amarillo Center for Clinical Research | Amarillo | Texas | 79124 | United States |
| Med Search Professional Group/Pharmaceutical C-Trials Inc. | Hurst | Texas | 76054 | United States |
| Texas Medical Research Associates | San Antonio | Texas | 78238 | United States |
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear |
| FG002 | Double-blind BTDS 20 | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
| FG003 | Double-blind Oxycodone Immediate-Release | Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind BTDS 5 | Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear |
| BG001 | Double-blind BTDS 20 | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
| BG002 | Double-blind Oxycodone Immediate-Release | Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). |
| BG003 | 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" Scores at Weeks 4, 8, and 12 of the Double-blind Phase. | The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12). | Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | Posted | Mean | Standard Error | Units on a scale | Weeks 4, 8, and 12 of the double-blind phase |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Mean Daily Number of Supplemental Analgesic Medication Tablets | The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®. | Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | Posted | Mean | Standard Error | Tablets | Double-blind phase (84 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase | The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete. The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst). | Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | Posted | Mean | Standard Error | Units on a scale | Weeks 4, 8 and 12 of the double-blind phase |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Sleep Disturbance Subscale in The Medical Outcomes (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 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 and Questions 2 to 12 are scored on a scale of 1 to 6. 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 = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | Posted | Mean | Standard Error | Units on a scale | Weeks 4, 8, and 12 of the Double-blind Phase |
|
Adverse Events (AEs) occurring after the signing of informed consent up to study completion or discontinuation; during 7 days after last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved.
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 5 | Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear during the 12-week double-blind phase | 3 | 136 | 30 | 136 | ||
| EG001 | Double-blind BTDS 20 | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear during the 12-week double-blind phase | 7 | 149 | 70 | 149 | ||
| EG002 | Double-blind Oxycodone Immediate-Release | Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours) during the 12-week double-blind phase. | 7 | 133 | 56 | 133 | ||
| EG003 | Run-in, Open-label BTDS 10 and 20 | The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period. | 8 | 652 | 187 | 652 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute abdomen | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Acute renal failure | Renal and urinary disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Acute cholecystitis | Hepatobiliary disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Chest pain | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Chest pain with ischemic episode | Cardiac disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Dermoid ovarian cyst | Congenital, familial and genetic disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Enlarged uterus | Reproductive system and breast disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Exacerbation of Crohn's disease | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Exacerbation of lumbar spinal stenosis | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Fall | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment "Fall" and "Fell" are listed as 2 separate categories. |
|
| Fell | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment "Fall" and "Fell" are listed as 2 separate categories. |
|
| Fractured left hip | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| GI bleeding | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Liver cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Muscle spasms right knee | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| OxyIR abuse | Social circumstances | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Palpitations | Cardiac disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Paroxysmal supraventricular tachycardia | Cardiac disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Postsurgical hip joint dislocation, left hip | Injury, poisoning and procedural complications | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Possible bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Prostatic adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Recurrent L4-L5 disc herniation | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Recurrent L5-S1 disc herniation with impingement of the S1 nerve root | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Renal calculi | Renal and urinary disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Transischemic attack | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Worsening asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Vomiting | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Acid reflux | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| End stage OA of the right knee | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Constipation | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Application site pruritus | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Application site rash | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Application site erythema | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Pain NOS | General disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Urinary tract infection NOS | Infections and infestations | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Headache | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Dizziness | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
| Somnolence | Nervous system disorders | MedDRA (5.1) | Systematic Assessment | Systematic and nonsystematic assessments. |
|
This study was terminated early for administrative reasons not related to safety or efficacy. Low enrollment at termination led to reduced power.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader, Medical Director | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| 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
| Adverse Event |
|
| Lost to Follow-up |
|
| Administrative |
|
| Lack of Efficacy |
|
| Male |
|
|
| Week 4 |
|
| Week 8 |
|
| Week 12 |
|
| 0.140 |
| Mean Difference (Final Values) |
| -0.36 |
| 95 |
| -0.8455 |
| 0.1189 |
Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase. |
| No |
| Superiority or Other |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|