Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
|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).
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|