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due to administrative reasons not related to efficacy or safety.
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The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.
Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.
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 10 | Experimental | Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear |
|
| BTDS 20 | Experimental | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
|
| BTDS 30 | Experimental | Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear |
|
| Placebo TDS | Placebo Comparator | Placebo patches were similar to BTDS 10 and 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety | Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved. | From signed informed consent to 7 days after end of study (approx. 35 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| Accurate Clinical Trials, Inc |
Enrolled: N = 14. Following surgery and recovery from anesthesia, subjects had to demonstrate moderate to severe pain within 6 hours postsurgery ("Pain Right Now" rating of ≥ 2 on a 4-point scale where 0 = no pain and 3 = severe pain), then their intravenous patient-controlled analgesia morphine device was activated. N = 10 were randomized.
Study start date: 02-Nov-2006 (first patient first visit) to 20-Apr-2007 (last patient last visit) at 5 medical/research centers in the US.
The study was terminated early due to reasons unrelated to efficacy or safety.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo transdermal patch applied for 7-day wear. |
| FG001 | BTDS 10 | Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. |
|
|
| Buprenorphine transdermal patch | Drug | Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear. |
|
|
| Placebo BTDS | Drug | Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear. |
|
| San Clemente |
| California |
| 92672 |
| United States |
| Southeastern Clinical Research Consultants | Orlando | Florida | 32804 | United States |
| Greater Chesapeake Orthopaedic Associates | Baltimore | Maryland | 21218 | United States |
| Sewickley Valley Hospital | Sewickley | Pennsylvania | 15143 | United States |
| FG002 | BTDS 20 | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
| FG003 | BTDS 30 | Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo transdermal patch applied for 7-day wear |
| BG001 | BTDS 10 | Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear |
| BG002 | BTDS 20 | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear |
| BG003 | BTDS 30 | Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear |
| BG004 | 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 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved. | The Safety Population consisted of subjects who were randomized, received at least 1 dose of double-blind study drug and had at least 1 safety assessment during double-blind treatment. | Posted | Number | participants | From signed informed consent to 7 days after end of study (approx. 35 days) |
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|
|
Adverse events are recorded up to 7 days after the last dose or until the last visit. Ongoing AEs at the last visit are followed until resolution or for 30 days after the visit. Serious AEs are followed until resolution or the event stabilize.
AEs 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 | Placebo | Placebo transdermal patch applied for 7-day wear. | 0 | 2 | 2 | 2 | ||
| EG001 | BTDS 10 | Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear | 0 | 3 | 2 | 3 | ||
| EG002 | BTDS 20 | Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear | 0 | 3 | 3 | 3 | ||
| EG003 | BTDS 30 | Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear | 0 | 2 | 2 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Vision blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Chills | General disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Gamma-Glutamyltransferase increased | Investigations | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Hallucinations | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Systematic and nonsystematic assessment |
|
This trial was terminated early due to administrative reasons not related to efficacy or safety. The efficacy data are not presented since the objective of this study was changed prior to study unblinding, identifying it as a safety study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader, Director of Clinical Research | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | 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 |
|
| Serious Adverse Events |
|
| All Other Adverse Events in ≥ 4.5% of subjects |
|