PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain

NCT ID: NCT01719757

Last Updated: 2016-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 359 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-04-30

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.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oxycodone/naloxone

Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day

Group Type: EXPERIMENTAL

Oxycodone/Naloxone

Intervention Type: DRUG

Twice daily

Interventions

Oxycodone/Naloxone

Twice daily

Intervention Type: DRUG

Other Intervention Names

Targin

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma Korea Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyeonghee Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Yeongnam Univ. hospital

Locations

13 sites including Yeungnam University Medical Center

Daegu, , South Korea

Countries

South Korea

Other Identifiers

OXN11-KR-404

Identifier Type: -

Identifier Source: org_study_id