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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Mundipharma Pte Ltd.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01719757
First received: October 8, 2012
Last updated: January 29, 2013
Last verified: October 2012
  Purpose

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.


Condition
Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • Change in numeric rating scales (NRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 4weeks ] [ Designated as safety issue: Yes ]
    Change in ECOG (Eastern Cooperative Oncology Group Performance at the time of the interview) from baseline (visit 1) to study end (visit 2)

  • Constipation assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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)

  • Overall satisfaction assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Final assessment of overall efficacy and tolerability by physician and patient


Estimated Enrollment: 512
Study Start Date: July 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Oxycodone/naloxone
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets provided in 56-tablet box. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary endpoint in the study is the change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours.

In the previous study (U. Schutter, S. Grunert, C. Meyer, T. Schmldt, T. Nolte. Innovative pain therapy with a fixed combination of prolonged-release oxycodone/naloxone: a large observational study under conditions of daily practice, Current Medical Research & Option), mean change in average pain levels is 2.5 and 95% confidence interval [2.3, 2.7]. Based on the result, standard deviation 4.73 is calculated.

In this study, standard deviation is assumed to be 4.73. Therefore, the sample size is 409 considering that significance level is 0.05, confidence interval ±0.46. The drop-out rate is considered by 20% then sample size is 512.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719757

Contacts
Contact: Yang Haeyoung, CRA 82-2-527-9223 haeyoung.yang@mundipharma.co.kr
Contact: Shin Ashley, CRM 82-2-527-9219 sunae.shin@mundipharma.co.kr

Locations
Korea, Republic of
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 705-717
Contact: Lee KyungHee, Ph.D    82 53 620 3845      
Principal Investigator: Yun HwanJung, Ph.D         
Principal Investigator: Song HongSuk, Ph.D         
Sponsors and Collaborators
Mundipharma Pte Ltd.
  More Information

No publications provided

Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT01719757     History of Changes
Other Study ID Numbers: OXN11-KR-404
Study First Received: October 8, 2012
Last Updated: January 29, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Mundipharma Pte Ltd.:
Targin, Cancer Pain

ClinicalTrials.gov processed this record on July 26, 2014