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| Name | Class |
|---|---|
| Napp Pharmaceuticals Limited | INDUSTRY |
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) 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 situations for the relief of moderate to severe pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTDS (5, 10 or 20) | Experimental | Buprenorphine transdermal patch |
|
| Placebo to match BTDS | Placebo Comparator | Placebo to match buprenorphine transdermal patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. | Ineffective treatment was defined as:
Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment. | Double-blind phase (14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment | The time of ineffective treatment was calculated as the earliest of the following:
| 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific exclusion/inclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawthorne and York | Phoenix | Arizona | 85008 | United States | ||
| Arizona Research Center Inc |
The Run-in period (N = 588 subjects started) consisted of titration from buprenorphine transdermal patch (BTDS) 5 to BTDS 10, or 20 mcg/h for tolerability. If BTDS was not tolerated or pain increased, the subject was discontinued. N = 267 subjects were randomized.
(First patient first visit) 19-Mar-2001 to (last patient last visit) 22-Jul-2001 at 42 centers: 21 in the UK and 21 in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind Placebo Patch | Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear. |
| FG001 | Double-blind BTDS | Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo to match BTDS | Drug | Placebo to match buprenorphine transdermal patch applied for 7-day wear. |
|
| The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase | Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS. | 14 days |
| The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets). | The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate. | 14 days |
| Phoenix |
| Arizona |
| 85023 |
| United States |
| Clinical Research Consultants Inc | Trumbull | Connecticut | 06611 | United States |
| Tampa Bay Medical Research Inc | Clearwater | Florida | 33761 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| University Clinical Research Deland | DeLand | Florida | 32702 | United States |
| University Clinical Research Inc, | Pembroke Pines | Florida | 33024 | United States |
| Gold Coast Research LLC | Plantation | Florida | 33324 | United States |
| Gold Coast Research LLC | Tamarac | Florida | 33321 | United States |
| Family Medicine Associates | Evansville | Indiana | 47712 | United States |
| Pain Management and Rehabilitation | Terre Haute | Indiana | 47802 | United States |
| Southeastern Center for Headache and Pain | Crestview Heights | Kentucky | 41017 | United States |
| Westside Family Medical Center PC | Kalamazoo | Michigan | 49009 | United States |
| The Arthritis Clinic | Charlotte | North Carolina | 28211 | United States |
| Cornerstone Research Care | High Point | North Carolina | 27262 | United States |
| ALL-TRIALS Clinical Research LLC | Winston-Salem | North Carolina | 27103 | United States |
| Private Practice | Chardon | Ohio | 44024 | United States |
| Summit Research Solutions | Memphis | Tennessee | 38119 | United States |
| Radiant Research | Austin | Texas | 78758 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Clinical Research Management | New Berlin | Wisconsin | 53151 | United States |
| Whiteabbey Health Centre | Newtownabbey | Belfast | BT37 9QN | United Kingdom |
| Antrim Coast Fundholding Group | Lame | Co Antrim | BT40 1XH | United Kingdom |
| Portglenone Health Centre | Portglenone | CO Antrim | BT44 8AD | United Kingdom |
| Garden Street Surgery | Magherafelt | Co Derry | BT45 5DD | United Kingdom |
| Springhill Surgery | Bangor | Co Down | BT19 1PP | United Kingdom |
| Bennett Road Surgery | Keresley End | Coventry | CV7 8LA | United Kingdom |
| Little Common Surgery | Bexhill-on-Sea | E Sussex | TN39 4SP | United Kingdom |
| Old Town Surgery | Bexhill-on-Sea | E Sussex | TN40 2HG | United Kingdom |
| Roebuck House Surgery | Hastings | E Sussex | TN34 3EY | United Kingdom |
| Leslie Surgery | Glenrothes | Fife | KY6 3LQ | United Kingdom |
| Valleyfield Health Centre | High Valleyfield | Fife | KY12 8SJ | United Kingdom |
| Townhead Health Centre | Glasgow | Glasgow | G31 2ES | United Kingdom |
| Castlemilk Health Centre | Glasgow | Glasgow | G45 9AW | United Kingdom |
| Ashvale Health Centre | Aldershot | Hants | GU12 5BA | United Kingdom |
| The Academy Medical Practice | Coatbridge | Lanarkshire | L5 3AP | United Kingdom |
| Sanbury Health Centre Group Practice | Sunbury-on-Thames | Middx | TW16 6RH | United Kingdom |
| Houston Surgery | Houston | Renfrewshire | PA6 7AR | United Kingdom |
| The Burns Practice | Doncaster | S Yorkshire | DN1 2EG | United Kingdom |
| Grosvenor Medical Centre | Royal Tunbridge Wells | W Sussex | TN1 2EP | United Kingdom |
| Gables Medical Section | Coventry | Warwickshire | CV6 4DD | United Kingdom |
| The Ridge Medical Practice, Great Horton | Bradford | West Yorkshire | BD7 3EE | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind Placebo Patch | Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear. |
| BG001 | Double-blind BTDS | Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h 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 |
| ||||||||||||||||
| 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 | The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase. | Ineffective treatment was defined as:
Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment. | The Full Analysis Population (N = 266) for efficacy analyses included all subjects who were randomized and provided at least 1 efficacy assessment in the double-blind phase. | Posted | Number | participants | Double-blind phase (14 days) |
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| Secondary | Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment | The time of ineffective treatment was calculated as the earliest of the following:
| Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase. | Posted | Mean | Standard Error | Days | 14 days |
|
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| Secondary | The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase | Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS. | Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase. | Posted | Number | participants | 14 days |
|
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| Secondary | The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets). | The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate. | Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase. | Posted | Least Squares Mean | Standard Error | Tablets | 14 days |
|
|
Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
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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 | Double-blind Placebo Patch | Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear. | 0 | 138 | 21 | 138 | ||
| EG001 | Double-blind BTDS | Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear. | 0 | 129 | 25 | 129 | ||
| EG002 | Open-label Run-in Period BTDS 5, 10 or 20 | Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear. | 7 | 588 | 245 | 588 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain abdominal | General disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Abscess | General disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Injury accidental | General disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Cellulitis | General disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Pain, chest | General disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Fibrillation, atrial | Cardiac disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Gastroenteritis | Immune system disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
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| Dehydration | Metabolism and nutrition disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Depression | Nervous system disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Asthenia | General disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Nausea | Gastrointestinal disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Vomit | Gastrointestinal disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Dizziness | Nervous system disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Somnolence | Nervous system disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Erythema at site | Skin and subcutaneous tissue disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
| Pruritus at site | Skin and subcutaneous tissue disorders | COSTART (5.0) | Systematic Assessment | Systematic and nonsystematic assessments |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader, Executive Medical Director | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
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| Male |
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| United Kingdom |
|
|
| Reason: required a change in TDS dose |
|
| Reason: difficulty keeping patch on |
|
| Reason: discontinued due to ineffective treatment |
|
| Superiority or Other |
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| Counts |
|---|
| Participants |
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