NCT01811238

An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders

A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of TARGIN(R) (Oxycodone/Naloxone) in Korean Patients With Spinal Disorders

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Mundipharma Korea Ltd · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Spinal Disorders

Interventions

Type	Name	Description
DRUG	Oxycodone/naloxone	Targin 5mg, 10mg, 20mg up to 40mg b.i.d

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-04-01
• Completion: 2013-07-01
• First posted: 2013-03-14
• Last updated: 2016-05-12
• Results posted: 2016-05-12