PROspective Non-interventional Open Label Trial for Assessment in Routine Practice of the Efficacy and the Safety of TARGIN ® in Korean Patients With Cancer Pain (PROBE)

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719757
• Other study ID #: OXN11-KR-404
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2012
• Last updated: July 7, 2015
• Start date: July 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Mundipharma Korea Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Oxycodone/Naloxone
Twice daily

Locations

Country	Name	City	State
Korea, Republic of	13 sites including Yeungnam University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Korea Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in numeric rating scales (NRS)	Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2)	4 weeks	No
Secondary	Quality of life	Change in Eastern Cooperative Oncology Group (ECOG) Performance at the time of the interview) from baseline (visit 1) to study end (visit 2)	4weeks	Yes
Secondary	Constipation assessment	Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)	4 weeks	Yes
Secondary	Overall satisfaction assessment	Final assessment of overall efficacy and tolerability by physician and patient	4 weeks	No