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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


N/A
20 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Change in numeric rating scales (NRS)

Outcome Description:

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)

Outcome Time Frame:

4 weeks

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

OXN11-KR-404

NCT ID:

NCT01719757

Start Date:

July 2012

Completion Date:

April 2014

Related Keywords:

  • Cancer
  • Targin, Cancer Pain

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