Spinal Disorders Related Pain Clinical Trial
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
Study Objectives:
1. Primary objective
- To assess the pain reduction after 8 weeks treatment from baseline (week 0)
2. Secondary objectives
- 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 (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
- Pregnancy
- Any other significant risk to the patient's safety in the clinical judgement of the
investigator
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care