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The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| buprenorphine | Experimental | Patch |
|
| tramadol/acetaminophen | Active Comparator | Oral tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine | Drug | Dosage and administration: This one patch should be attached every 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment. | NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline. | baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration | NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinhyok Kim, Dr.PhD | Sanggye Paik Hospital, Dept. of Orthopedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanggye Paik Hospital, Dept. of Orthopedic Surgery | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29056859 | Derived | Lee JH, Kim JH, Kim JH, Kim HS, Min WK, Park YS, Lee KY, Lee JH. Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery. Pain Res Manag. 2017;2017:2071494. doi: 10.1155/2017/2071494. Epub 2017 Sep 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine | Patch buprenorphine: Dosage and administration: This one patch should be attached every 7 days. |
| FG001 | Tramadol/Acetaminophen | Oral tablet tramadol/acetaminophen: Amount of drug ingredients : Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug. Dosage and administration: Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
* Safety set = 134
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine | Patch buprenorphine: Dosage and administration: This one patch should be attached every 7 days. |
| BG001 | Tramadol/Acetaminophen | Oral tablet tramadol/acetaminophen: Amount of drug ingredients : Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug. Dosage and administration: Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets. |
| 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 |
| 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 in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment. | NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline. | In the PP set, the change in the pain intensity score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | baseline and 6 weeks |
|
from baseline to 6 weeks
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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 | Buprenorphine | Patch buprenorphine: Dosage and administration: This one patch should be attached every 7 days. Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 69 subjects who administered the study drug(buprenorphine) and had at least one time of safety assessment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | This case was not related with study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment | These cases were related with study drug & comparator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PhD. Miyoung Song | Mundipharma Korea Ltd. | miyoung.song@mundipharma.co.kr |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| C478659 | Ultracet |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| tramadol/acetaminophen | Drug | Amount of drug ingredients : Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug. Dosage and administration: Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets. |
|
|
| Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose | EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for 'Motor capability', 'Self-care', 'Daily activities', 'Pain/discomfort', 'Depression/anxiety' and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life. | Baseline and at 6 weeks |
| Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS) | The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results. | Baseline and at 6weeks |
| Clinical Global Impression of Change(CGIC) | The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse. | 6 weeks |
| Patient Global Impressions of Change(PGIC) | In the PP set, Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). | 6 weeks |
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Oral tablet tramadol/acetaminophen: Amount of drug ingredients : Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug. Dosage and administration: Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets. |
|
|
|
| Secondary | Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration | NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline. | In the PP set, the reduction in the pain intensity score from Visit 1 (Baseline) to Week 2 of the investigational product administration was analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | 2 weeks |
|
|
|
| Secondary | Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose | EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for 'Motor capability', 'Self-care', 'Daily activities', 'Pain/discomfort', 'Depression/anxiety' and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life. | In the PP set, the change in the quality of life (EQ-5D) total score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed. | Posted | Mean | Standard Deviation | EQ-5D Total score | Baseline and at 6 weeks |
|
|
|
| Secondary | Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS) | The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results. | In the PP set, the change in the your today health score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and at 6weeks |
|
|
|
| Secondary | Clinical Global Impression of Change(CGIC) | The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse. | In the per protocol: Analyze the within-group change in the CGIC from Baseline (Week 0) to Week 6 of the investigational product administration by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test. | Posted | Mean | Standard Deviation | Scores on 1 to 7 point | 6 weeks |
|
|
|
| Secondary | Patient Global Impressions of Change(PGIC) | In the PP set, Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). | Per protocol set: Analyze the within-group change in the PGIC from Baseline (Week 0) to Week 6 by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test. | Posted | Mean | Standard Deviation | Scores on 1 to 7point | 6 weeks |
|
|
|
| 3 |
| 69 |
| 18 |
| 69 |
| EG001 | Tramadol/Acetaminophen | Oral tablet tramadol/acetaminophen: Amount of drug ingredients : Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug. Dosage and administration: Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets. Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 65 subjects who administered the comparator(tramadol/acetaminophen) and had at least one time of safety assessment. | 0 | 65 | 13 | 65 |
|
| Post procedural infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment | These cases were not related with study drug. |
|
|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Gastric disorder | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Post procedural infection | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Herpes zoster | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
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| 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 |