Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
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|ClinicalTrials.gov Identifier: NCT01983111|
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: buprenorphine Drug: tramadol/acetaminophen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Dosage and administration: This one patch should be attached every 7 days.
Other Name: Norspan patch
Active Comparator: 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.
Other Name: Ultracet ER semi
- Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment. [ Time Frame: baseline and 6 weeks ]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.
- Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration [ Time Frame: 2 weeks ]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 [ Time Frame: Baseline and at 6 weeks ]
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) [ Time Frame: Baseline and at 6weeks ]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) [ Time Frame: 6 weeks ]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) [ Time Frame: 6 weeks ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983111
|Korea, Republic of|
|Sanggye Paik Hospital, Dept. of Orthopedic Surgery|
|Seoul, Korea, Republic of|
|Principal Investigator:||Jinhyok Kim, Dr.PhD||Sanggye Paik Hospital, Dept. of Orthopedic Surgery|