Clinical trial NCT01719757: PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain
Official title: A 4-week, Open Label, Multi-center, Prospective, Single-arm, Non-interventional Phase IV Study to Evaluate the Efficacy of Targin for the Treatment of Korean Patients With Cancer Pain Under Conditions of Daily Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Keywords: Targin, Cancer Pain
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2012-11-01
Enrollment: 359
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: An open-label, multi-center, nonrandomized, prospective, non-interventional, observational phase IV trial.

At the first visit, a detailed medical history is taken, including previous analgesics and concomitant treatment. After inclusion, patients enter a 4-week observation period during which they will receive bid of TARGIN 10/5mg and/or 20/10mg. The dose adjustments of TARGIN as well as of analgesic co-medication, rescue-medication and other treatments (e.g. laxatives) can be performed at any time-point during the observation period by the physician in dependence of medical demand. The asymmetric dose is allowed during the observation period by the physician's judgment. (e.g. 10/5 mg in the morning and 20/10 mg in the evening).

Data are gathered using interview-administered questionnaires at baseline (visit 1) and study end (visit 2).

During the observation period, unscheduled visits are allowed after the first visit due to inadequate pain control or occurrence of adverse events.

Eligibility criteria: Inclusion Criteria:

1. Male or female cancer patients 20 years of age or older
2. Cancer related pain that requires treatment with continuous around-the-clock strong opioid analgesic
3. Moderate to severe pain intensity (NRS pain score \>=4)
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
5. Ability to communicate effectively with the study personnel regarding pain intensity, constipation assessment, final assessment of overall efficacy and tolerability
6. Subject who provide signed and dated written voluntary informed consent

Exclusion Criteria:

1. Pregnant or nursing (lactating) women
2. Have previously received treatment with Targin
3. Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration
4. Any history of hypersensitivity to Oxycodone and Naloxone or any excipients
5. Patients with significant respiratory depression
6. Patients with acute or severe bronchial asthma or hypercarbia
7. Any patient who has or is suspected of having paralytic ileus
8. Severe Chronic obstructive pulmonary disease, pulmonary heart disease
9. Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
10. Patients with moderate and severe hepatic impairment
11. 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)
12. Any situation where opioids are contraindicated
13. With a life expectancy \< 1 month
14. Any situation where opioids are contraindicated
15. Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)
16. 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
17. Patients with uncontrolled seizures
18. Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
19. With a history of alcohol abuse within 6 months of screening
20. With a history of illicit drug abuse within 6 months of screening
21. Patients with increased intracranial pressure
22. Having used other investigational drugs at the time of enrollment, or within 30 days.

Primary outcomes:
measure: Change in Numeric Rating Scales (NRS) Score
timeFrame: 4 weeks
Secondary outcomes:
measure: Change of Eastern Cooperative Oncology Group(ECOG) Performance Status
timeFrame: 4weeks
measure: Change of Constipation Assessment From Baseline to Visit 2(End Visit)
timeFrame: 4 weeks
measure: Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: 13 sites including Yeungnam University Medical Center
Study officials:
affiliation: Yeongnam Univ. hospital
name: Kyeonghee Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: