Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
Primary Purpose
Pain
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
buprenorphine
tramadol/acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- Korean men and women aged 20 years or more
- Presence of pain associated with a spinal disease and lumbar fusion at 1-2 spinal segments (1-2 level lumbar fusion surgery)
- Moderate to severe pain of the NRS pain score ≥ 4 at Visit 1 (14~90 days after surgery, Baseline) (Amended 21Nov2013)
- Consent to participate in the study and voluntary signature on the informed consent form
Exclusion Criteria:
- Women of childbearing potential, except for the following cases:
- A partner who is vasectomized or otherwise surgically sterile.
- Use of 2 contraception methods. Two methods include the combination of double-barrier contraception or barrier contraception and hormone contraception, and appropriate barrier methods are as follows: Diaphragm (female contraceptive device), condom, intrauterine (copper or hormone), sponge or spermicide. Hormonal contraceptives include all commercially available products containing estrogen and/or progesterone.
- Pregnant or breastfeeding women. Pregnant woman is defined as a woman after fertilization to late pregnancy with a positive result from the urine pregnancy test.
- History of hypersensitivity to buprenorphine, tramadol, APAP or excipients, and celecoxib
- Medical history of asthma, acute rhinitis, nasal polyp, vascular edema urticaria or allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs(NSAIDs, COX-2)
- Hypersensitivity or intolerance to Domperidone
- Risk of gastrointestinal irritation such as gastrointestinal bleeding, mechanical ileus or perforation
- Genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Severely impaired respiratory function or respiratory depression
- Current use of monoamine oxidase(MAO) inhibitors or the medication history within 2 weeks prior to study participation
- Convulsive disorder, head injury, shock, decreased level of consciousness of uncertain origin, intracranial lesion or increased intracranial pressure or severe hepatic impairment
- Biliary tract disorder
- Presence or suspected drug abuse history
- Medical history of opioid or drug dependence
- Current use of other CNS inhibitors or muscle relaxants that may result in dyspnea, hypotension, severe sedation or coma when used with the investigational product, opioid analgesics
- Use of strong opioids, buprenorphine or tramadol/APAP within 1 week prior to study participation (however, study participation is allowed for PRN prescription of PCA and strong opioids)
- Any condition representing a contraindication of application of buprenorphine, tramadol/APAP or celecoxib
- Major pain not attributable to a spinal disease
- Anticancer therapy that may affect pain assessment
- Clinically significant cardiovascular or renal dysfunction
- Postoperative complications
- Symptoms of acute pain after lumbar fusion or characteristic analgesic features showing rapidly changing needs for analgesics
- Current use of other investigational product at enrollment or within 30 days after administration of other investigational product
Sites / Locations
- Sanggye Paik Hospital, Dept. of Orthopedic Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
buprenorphine
tramadol/acetaminophen
Arm Description
Patch
Oral tablet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01983111
Brief Title
Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
Official Title
A Multicenter, Phase IV, Interventional Study to Compare the Efficacy and Safety of NORSPAN to Tramadol/Acetaminophen in Patients With Prolonged Postoperative Pain After Spinal Surgery (PASSION)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
buprenorphine
Arm Type
Experimental
Arm Description
Patch
Arm Title
tramadol/acetaminophen
Arm Type
Active Comparator
Arm Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
buprenorphine
Other Intervention Name(s)
Norspan patch
Intervention Description
Dosage and administration: This one patch should be attached every 7 days.
Intervention Type
Drug
Intervention Name(s)
tramadol/acetaminophen
Other Intervention Name(s)
Ultracet ER semi
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.
Description
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.
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration
Description
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.
Time Frame
2 weeks
Title
Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose
Description
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.
Time Frame
Baseline and at 6 weeks
Title
Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)
Description
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.
Time Frame
Baseline and at 6weeks
Title
Clinical Global Impression of Change(CGIC)
Description
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.
Time Frame
6 weeks
Title
Patient Global Impressions of Change(PGIC)
Description
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).
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Korean men and women aged 20 years or more
Presence of pain associated with a spinal disease and lumbar fusion at 1-2 spinal segments (1-2 level lumbar fusion surgery)
Moderate to severe pain of the NRS pain score ≥ 4 at Visit 1 (14~90 days after surgery, Baseline) (Amended 21Nov2013)
Consent to participate in the study and voluntary signature on the informed consent form
Exclusion Criteria:
Women of childbearing potential, except for the following cases:
A partner who is vasectomized or otherwise surgically sterile.
Use of 2 contraception methods. Two methods include the combination of double-barrier contraception or barrier contraception and hormone contraception, and appropriate barrier methods are as follows: Diaphragm (female contraceptive device), condom, intrauterine (copper or hormone), sponge or spermicide. Hormonal contraceptives include all commercially available products containing estrogen and/or progesterone.
Pregnant or breastfeeding women. Pregnant woman is defined as a woman after fertilization to late pregnancy with a positive result from the urine pregnancy test.
History of hypersensitivity to buprenorphine, tramadol, APAP or excipients, and celecoxib
Medical history of asthma, acute rhinitis, nasal polyp, vascular edema urticaria or allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs(NSAIDs, COX-2)
Hypersensitivity or intolerance to Domperidone
Risk of gastrointestinal irritation such as gastrointestinal bleeding, mechanical ileus or perforation
Genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Severely impaired respiratory function or respiratory depression
Current use of monoamine oxidase(MAO) inhibitors or the medication history within 2 weeks prior to study participation
Convulsive disorder, head injury, shock, decreased level of consciousness of uncertain origin, intracranial lesion or increased intracranial pressure or severe hepatic impairment
Biliary tract disorder
Presence or suspected drug abuse history
Medical history of opioid or drug dependence
Current use of other CNS inhibitors or muscle relaxants that may result in dyspnea, hypotension, severe sedation or coma when used with the investigational product, opioid analgesics
Use of strong opioids, buprenorphine or tramadol/APAP within 1 week prior to study participation (however, study participation is allowed for PRN prescription of PCA and strong opioids)
Any condition representing a contraindication of application of buprenorphine, tramadol/APAP or celecoxib
Major pain not attributable to a spinal disease
Anticancer therapy that may affect pain assessment
Clinically significant cardiovascular or renal dysfunction
Postoperative complications
Symptoms of acute pain after lumbar fusion or characteristic analgesic features showing rapidly changing needs for analgesics
Current use of other investigational product at enrollment or within 30 days after administration of other investigational product
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhyok Kim, Dr.PhD
Organizational Affiliation
Sanggye Paik Hospital, Dept. of Orthopedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanggye Paik Hospital, Dept. of Orthopedic Surgery
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29056859
Citation
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.
Results Reference
derived
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Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
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