An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders (TALENT)
- To assess the pain reduction after 8 weeks treatment from baseline (week 0)
- To assess the pain reduction after 4 weeks treatment from baseline (week 0)
- To assess the EQ-5D
- To assess physician's overall satisfaction
- To assess subject's overall satisfaction
- To assess safety
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of TARGIN(R) (Oxycodone/Naloxone) in Korean Patients With Spinal Disorders|
- 24hr pain intensity score (Numeric rating score: 0 -10) [ Time Frame: 8 week ] [ Designated as safety issue: No ]The primary efficacy outcome is the actual reduction of pain intensity (Numeric rating score: 0 -10) score (average pain over 24 hours obtained at each visit) after 8 weeks treatment from baseline.
- EuroQol-5 Dimension(EQ-5D) [ Time Frame: 8 week ] [ Designated as safety issue: No ]
There are 3 statements in each question below to place a tick in one statement. A subject will indicate which statements best describe his/her own health state today.
- Usual Activities (e.g.work, study, housework, family or leisure activities)
And a subject will indicate on a scale (score: 0-100) how good or bad his/her own health is today.
- Overall satisfaction of Physicians and subjects [ Time Frame: 8 week ] [ Designated as safety issue: No ]
Physicians will choose the best opinion of his/her overall satisfaction among Clinical Global Impression of Change Scale(CGIC) 7 point scale.
Subjects will choose the best opinion of his/her overall satisfaction among Patient Global Impression of Change Scale(PGIC) 7 point scale.
- 24hr pain intensity score (Numeric rating score: 0 -10) [ Time Frame: 4 week ] [ Designated as safety issue: No ]The secondary efficacy outcome is the actual reduction of pain intensity (Numeric rating score: 0 -10) score (average pain over 24 hours obtained at each visit) after 4 weeks treatment from baseline.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
8 weeks treatment with Oxycodone/Naloxone
Other Name: Oxycodone/Naloxone
Study Design (Methodology):
This will be a multicenter, phase IV, interventional study to assess the efficacy and safety of TARGIN(R)(Oxycodone/Naloxone) in Korean patients who are dissatisfied with their current analgesic medication (WHO step II analgesics).
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, 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 TARGIN(R). Re-screening, study drug dose interruption is not allowed. The duration of study drug dose interruption is defined as for 1 week.
Treatment with TARGIN(R) will be started at 5/2.5mg b.i.d.,and proper titration (up titration) will be allowed at each visit or at unscheduled visit according to the investigator's decision. On-site visit or phone call will be allowed for visit 2(wk 1).The up titration will be considered by investigator's judgement as followings; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average numerical rating scale
, if the numerical rating scale 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). Pain assessment by investigator at each visit will be used for analysis and criteria for uptitration. Daily pain diary will be used for only criteria for uptitration.
Safety laboratories will be obtained at baseline (visit 1) and study end (visit 4) in a local laboratory. The laboratory values within 4 weeks prior to baseline (visit 1) will be allowed to use at study visit 1.
The rescue medication is the IRcodon(R).
Patients will be withdrawn from the study if the following circumstance require study drug discontinuation:
- Failure of pain control (Failure of pain control will be decided by investigators judgement, e.g. there is poor pain control or lack of efficacy despite 2~3 times of titration.)
- Adjustment of the other analgesics due to Adverse event except TARGIN(R) or IRcodon(R)
- Adjustment of the other major pain management modality (e.g. surgery, non-surgical interventional therapy, etc.)
- Withdrawal of informed consent
- Any other significant risk to the patient's safety in the clinical judgement of the investigator
Please refer to this study by its ClinicalTrials.gov identifier: NCT01811238
|Contact: Sung Soo Chungemail@example.com|
|Contact: Junhee Kangfirstname.lastname@example.org|
|Korea, Republic of|
|Chungbuk National University||Not yet recruiting|
|Cheongju-si, Chungbukdo, Korea, Republic of, 123-456|
|Hanyang University Guri Hospital||Not yet recruiting|
|Guri-si, Gyeonggi-do, Korea, Republic of, 471-701|
|Dong-A University Medical Center||Not yet recruiting|
|Busan, Korea, Republic of, 602-715|
|Chungnam National University Hospital||Not yet recruiting|
|Daejeon, Korea, Republic of, 301-721|
|Inha University Hospital||Recruiting|
|Incheon, Korea, Republic of, 400-711|
|Asan Medical Center||Not yet recruiting|
|Seoul, Korea, Republic of, 138-736|
|Severance Hospital, Yonsei University Health System||Not yet recruiting|
|Seoul, Korea, Republic of, 120-752|
|SMG - SNU Boramae Medical Center||Recruiting|
|Seoul, Korea, Republic of, 156-707|
|Inje University Sanggye Paik Hospital||Recruiting|
|Seoul, Korea, Republic of, 139-707|
|Principal Investigator:||Sung Soo Shung||Samsung Medical Center|