Trial Outcomes & Findings for Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION) (NCT NCT01983111)
NCT ID: NCT01983111
Last Updated: 2016-07-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
136 participants
Primary outcome timeframe
baseline and 6 weeks
Results posted on
2016-07-11
Participant Flow
Participant milestones
| Measure |
Buprenorphine
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
66
|
|
Overall Study
COMPLETED
|
58
|
59
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Buprenorphine
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
Baseline characteristics by cohort
| Measure |
Buprenorphine
n=69 Participants
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
Tramadol/Acetaminophen
n=65 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.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Continuous
|
64.42 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
61.54 years
STANDARD_DEVIATION 8.96 • n=7 Participants
|
63.02 years
STANDARD_DEVIATION 10.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Buprenorphine
n=47 Participants
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
Tramadol/Acetaminophen
n=40 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.
|
|---|---|---|
|
Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.
|
-2.32 Scores on a scale
Standard Deviation 1.96
|
-2.75 Scores on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Buprenorphine
n=47 Participants
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
Tramadol/Acetaminophen
n=40 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.
|
|---|---|---|
|
Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration
|
-1.19 Scores on a scale
Standard Deviation 1.61
|
-1.70 Scores on a scale
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Baseline and at 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Buprenorphine
n=47 Participants
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
Tramadol/Acetaminophen
n=40 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.
|
|---|---|---|
|
Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose
|
0.09 EQ-5D Total score
Standard Deviation 0.19
|
0.21 EQ-5D Total score
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline and at 6weeksPopulation: 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.
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.
Outcome measures
| Measure |
Buprenorphine
n=47 Participants
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
Tramadol/Acetaminophen
n=40 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.
|
|---|---|---|
|
Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)
|
14.33 scores on a scale
Standard Deviation 20.34
|
9.08 scores on a scale
Standard Deviation 19.63
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Buprenorphine
n=47 Participants
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
Tramadol/Acetaminophen
n=40 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.
|
|---|---|---|
|
Clinical Global Impression of Change(CGIC)
|
2.28 Scores on 1 to 7 point
Standard Deviation 1.21
|
2.43 Scores on 1 to 7 point
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Buprenorphine
n=47 Participants
Patch
buprenorphine: Dosage and administration: This one patch should be attached every 7 days.
|
Tramadol/Acetaminophen
n=40 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.
|
|---|---|---|
|
Patient Global Impressions of Change(PGIC)
|
2.32 Scores on 1 to 7point
Standard Deviation 1.22
|
2.45 Scores on 1 to 7point
Standard Deviation 0.93
|
Adverse Events
Buprenorphine
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Tramadol/Acetaminophen
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buprenorphine
n=69 participants at risk
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.
|
Tramadol/Acetaminophen
n=65 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Infections and infestations
Post procedural infection
|
2.9%
2/69 • Number of events 2 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
Other adverse events
| Measure |
Buprenorphine
n=69 participants at risk
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.
|
Tramadol/Acetaminophen
n=65 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.8%
4/69 • Number of events 4 • from baseline to 6 weeks
|
6.2%
4/65 • Number of events 4 • from baseline to 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.2%
5/69 • Number of events 6 • from baseline to 6 weeks
|
4.6%
3/65 • Number of events 3 • from baseline to 6 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/69 • from baseline to 6 weeks
|
3.1%
2/65 • Number of events 2 • from baseline to 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
2/69 • Number of events 2 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Gastrointestinal disorders
Gastric disorder
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
General disorders
Application site pruritus
|
4.3%
3/69 • Number of events 3 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
General disorders
Application site erythema
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
General disorders
Chills
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
General disorders
Oedema
|
0.00%
0/69 • from baseline to 6 weeks
|
1.5%
1/65 • Number of events 1 • from baseline to 6 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/69 • from baseline to 6 weeks
|
4.6%
3/65 • Number of events 3 • from baseline to 6 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/69 • from baseline to 6 weeks
|
4.6%
3/65 • Number of events 3 • from baseline to 6 weeks
|
|
Investigations
Haemoglobin decreased
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
1.5%
1/65 • Number of events 1 • from baseline to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/69 • Number of events 2 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Nervous system disorders
Dizziness
|
2.9%
2/69 • Number of events 2 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Nervous system disorders
Headache
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Nervous system disorders
Post procedural infection
|
2.9%
2/69 • Number of events 2 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
|
Nervous system disorders
Herpes zoster
|
0.00%
0/69 • from baseline to 6 weeks
|
1.5%
1/65 • Number of events 1 • from baseline to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/69 • from baseline to 6 weeks
|
1.5%
1/65 • Number of events 1 • from baseline to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/69 • from baseline to 6 weeks
|
1.5%
1/65 • Number of events 1 • from baseline to 6 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/69 • from baseline to 6 weeks
|
1.5%
1/65 • Number of events 1 • from baseline to 6 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/69 • from baseline to 6 weeks
|
1.5%
1/65 • Number of events 1 • from baseline to 6 weeks
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
1.4%
1/69 • Number of events 1 • from baseline to 6 weeks
|
0.00%
0/65 • from baseline to 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place