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

Mundipharma

Status and phase

Completed

Phase 4

Conditions

Spinal Disorders

Treatments

Drug: Oxycodone/naloxone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01811238

OXN12-KR-401

Details and patient eligibility

About

Study Objectives:

Primary objective
- To assess the pain reduction after 8 weeks treatment from baseline (week 0)
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

Full 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

Enrollment

240 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female ≥ 20 and <80 years of age
Patients who have spinal disorders related pain for over 90days
Patients who have moderate to severe pain intensity which is not controlled with weak opioids or NSAIDs: NRS ≥ 4
Naïve patients for Oxycodone/Naloxone
Naïve patients for strong opioid
Patients who signed a written informed consent form

Exclusion criteria

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
Patients with severe respiratory depression with hypoxia and/or hypercapnoea
Patients with severe chronic obstructive pulmonary disease
Patients with cor pulmonale
Patients with severe bronchial asthma
Patients who have been diagnosed or is suspected of having paralytic or obstructive ileus.Patients with moderate to severe hepatic impairment
Targin(R) product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>2.5 times the upper limit of normal, it is allowed >5 times the upper limit of normal in case of transition in liver) or an abnormal total bilirubin and/or creatinine level (s)(greater than 1.5 times the upper limit of normal), gamma glutamyl transpeptidase (GGT or GGTP) ≥ 3 times the upper limit of normal
Patients with uncontrolled seizures
Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
Patients with increased intracranial pressure
In the investigator's opinion, subjects who are receiving hypnotics or central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication
Patients with myxodema, not adequately treated hypothyroidism or Addisons disease
Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine)
Clinically significant impairment of cardiovascular, respiratory and renal function
Major surgery within 1 month prior to screening or planned surgery
Mainly pain originated other than spinal disorders disease
Non-malignant patients or cancer patients who are receiving any oncology treatment that could affect the measure of pain control
Patients with uncontrolled constipation regardless of laxative use and/or laxative type
With a disability that may prevent the patient from completing all study requirements and in particular, interfere with 24hrs pain intensity score
Patients known to have, or suspected of having a history of drug abuse
Patients with history of opioid or drug dependence
Any situation where opioids are contraindicated
Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
Having used other investigational drugs at the time of enrollment

No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.