Status:
COMPLETED
An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders
Lead Sponsor:
Mundipharma Korea Ltd
Conditions:
Spinal Disorders
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief 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 trea...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01811238
Start Date
September 1 2012
End Date
July 1 2013
Last Update
May 12 2016
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