Phase 4
Completed N=359
PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain
Source: ClinicalTrials.gov NCT01719757 ↗Enrolled (actual)
359
Serious AEs
14.2%
Results posted
Aug 2016
Primary outcomePrimary: Change in Numeric Rating Scales (NRS) Score — -1.89 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under conditions of daily practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Numeric Rating Scales (NRS) Score |
-1.89 | — |
| SECONDARY Change of Eastern Cooperative Oncology Group(ECOG) Performance Status |
0.08 | — |
| SECONDARY Change of Constipation Assessment From Baseline to Visit 2(End Visit) |
-0.03 | — |
| SECONDARY Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject |
24; 12; 80; 78; 146; 156 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female cancer patients 20 years of age or older
- Cancer related pain that requires treatment with continuous around-the-clock strong opioid analgesic
- Moderate to severe pain intensity (NRS pain score >=4)
- Opioid naïve patients or patients not treated with strong opioids (Only except occasional PRN) within 13 months or patients who has been on weak opioids
- Ability to communicate effectively with the study personnel regarding pain intensity, constipation assessment, final assessment of overall efficacy and tolerability
- Subject who provide signed and dated written voluntary informed consent
Exclusion Criteria
- Pregnant or nursing (lactating) women
- Have previously received treatment with Targin
- Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration
- Any history of hypersensitivity to Oxycodone and Naloxone or any excipients
- Patients with significant respiratory depression
- Patients with acute or severe bronchial asthma or hypercarbia
- Any patient who has or is suspected of having paralytic ileus
- Severe Chronic obstructive pulmonary disease, pulmonary heart disease
- Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
- Patients with moderate and severe hepatic impairment
- 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)
- Any situation where opioids are contraindicated
- With a life expectancy < 1 month
- Any situation where opioids are contraindicated
- Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)
- Patients with known or suspected unstable brain metastases or spinal cord compression that may require changes in steroid treatment throughout the duration of the study
- Patients with uncontrolled seizures
- Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
- With a history of alcohol abuse within 6 months of screening
- With a history of illicit drug abuse within 6 months of screening
- Patients with increased intracranial pressure
- Having used other investigational drugs at the time of enrollment, or within 30 days.
Data sourced from ClinicalTrials.gov (NCT01719757). 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.