Phase 4
Completed N=240
An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders
Spinal Disorders
Source: ClinicalTrials.gov NCT01811238 ↗
Enrolled (actual)
240
Serious AEs
1.4%
Results posted
May 2016
Primary outcomePrimary: Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS. — -1.69 scores on a scale — p=<0.05
◆ Published Evidence
Emerging
9citations · ~1 / year
Analgesic Efficacy and Safety of Prolonged-Release Oxycodone/Naloxone in Korean Patients with Chronic Pain from Spinal Disorders.
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
Linked Publications
-
Analgesic Efficacy and Safety of Prolonged-Release Oxycodone/Naloxone in Korean Patients with Chronic Pain from Spinal Disorders.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS. |
-1.69 | <0.05 sig |
| SECONDARY The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline |
0.15 | <0.05 sig |
| SECONDARY Clinical Global Impression of Change(CGIC) |
20; 49; 70; 57; 6; 5 | — |
| SECONDARY Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline |
-1.36 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS) |
10.57 | — |
| SECONDARY Patient Global Impression of Change(PGIC) |
16; 49; 69; 60; 6; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 20 and 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.
Data sourced from ClinicalTrials.gov (NCT01811238) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.