An Interventional Study to Assess the Efficacy and Safety of Buprenorphine in Korean Patients With Spinal Disorders (NOBLE)
|ClinicalTrials.gov Identifier: NCT01818700|
Recruitment Status : Completed
First Posted : March 26, 2013
Results First Posted : September 22, 2015
Last Update Posted : October 22, 2015
The purpose of this study is to assess the pain reduction rate after 8 weeks treatment of NORSPAN® from baseline.
And secondary purpose are: pain reduction rate after 4 weeks treatment from baseline(week 0) the EQ-5D, the pain and sleep questionnaire, physician's overall satisfaction subject's overall satisfaction, and safety
|Condition or disease||Intervention/treatment||Phase|
|Spinal Disorder||Drug: Buprenorphine||Phase 4|
Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score, EQ-5D, pain and sleep questionnaire, physician's overall satisfaction and subject's overall satisfaction.
If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will receive treatment with NORSPAN®.
Treatment with NORSPAN® will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of NORSPAN® (Buprenorphine) in Korean Patients With Spinal Disorders (NOBLE)|
|Study Start Date :||September 2012|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Single arm-Norspan patch (Buprenorphine)
This trial is single arm with Norspan patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator's decision. The up-titration will be considered by investigator's judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
8weeks treatment with Norspan®(Buprenorphine)
- Change of Pain Intensity* at Week 8 of Treatment With the Study Drug From Baseline [ Time Frame: 8 weeks ]NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 8/ET minus mean score at Baseline.
- Change of Pain Intensity at 4 Week of Treatment With Study Srug From Baseline. [ Time Frame: 4 weeks ]NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 4/ET minus mean score at Baseline.
- Change in Quality of Life at 8 Week of Treatment With Study Drug From Baseline [ Time Frame: 8 weeks ]
The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.
EQ-5D score = 1 - 0.081 - (relevant score by level for the relevant item)-0.269 (only if there is at least one level 3).
Table of scores by level for EQ-5D items mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.236).
- Change of EQ-VAS at 8 Weeks of Treatment With Study Drug From Baseline. [ Time Frame: 8 week ]EQ-5D Visual Analogue Scale (VAS) in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable).
- Clinician Global Impression of Change(CGIC) [ Time Frame: 8weeks ]Number of clinician with categorical change in overall status. CGIC: a clinician-rated instrument assessing change in clinician's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).
- Patients Global Impression og Change(PGIC) [ Time Frame: 8 week ]Number of clinician with categorical change in overall status. PGIC: a participant-rated instrument assessing change in patient's overall status 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): NCT01818700
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Whan Eoh||Samsung Medical Center|