A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients (TOP)

This study is currently recruiting participants.
Verified March 2013 by Mundipharma Pte Ltd.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier:
NCT01313780
First received: March 8, 2011
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

Objectives:

To prove non-inferiority of Targin compared to Oxycontin in terms of reduction of pain intensity

  1. Primary objective: Actual reduction of pain intensity (0-10) score (average pain over 24 hours obtained each evening) within 4 weeks
  2. Secondary objectives: Bowel Habit (worsening/no change/improving), Total dose and frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need of laxative use and Adverse events, Long term safety and efficacy

Condition Intervention Phase
Cancer
Drug: oxycodone and naloxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 4-week Multicentre, Randomized, Open Label, Parallel Group, Active Control Phase IV Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone in Comparison With Oxycontin in Korean Patients With Cancer Pain(TOP)

Resource links provided by NLM:


Further study details as provided by Mundipharma Pte Ltd.:

Primary Outcome Measures:
  • Assess reduction of pain intensity [ Time Frame: NRS will be captured at 4 weeks ] [ Designated as safety issue: No ]
    Actual reduction of pain intensity (0-10) score (average pain over 24 hours obtained each evening) within 4 weeks through measuring pain intensity with NRS (Numeric Rating Scale).


Secondary Outcome Measures:
  • Efficacy parameters including long term safety and efficacy [ Time Frame: They will be assessed at 4 weeks ] [ Designated as safety issue: Yes ]
    Bowel Habit (worsening/no change/improving), Total dose and frequency of rescue medication, Quality of Life (QOL; EORTC QLQ-C30), Duration to need of laxative use and Adverse events, Long term safety and efficacy


Estimated Enrollment: 128
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxycodone and Naloxone
Daily dose can be titrated up to 40mg B.I.D.
Drug: oxycodone and naloxone
Trade name is TARGIN. Oxycodone (10mg)/naloxone(5mg) or Oxycodone(20mg)/naloxone(10mg) tablets provided in 56-tablet box. Twice daily per oral
Other Names:
  • TARGIN: Oxycodone and Naloxone
  • OXYCONTIN: Oxycodone
Active Comparator: Oxycodone Drug: oxycodone and naloxone
Trade name is TARGIN. Oxycodone (10mg)/naloxone(5mg) or Oxycodone(20mg)/naloxone(10mg) tablets provided in 56-tablet box. Twice daily per oral
Other Names:
  • TARGIN: Oxycodone and Naloxone
  • OXYCONTIN: Oxycodone

Detailed Description:

This will be a 4-week multicentre, randomized, open label, parallel group, active control study to evaluate efficacy and safety of Targin in comparison with Oxycontin in Korean patients with cancer pain who are administered weak opioid or naïve patients including patient not on the long term strong opioid medication within 3 months.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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(except PRN) within 4 weeks or patients who has been on weak opioids
  5. Subject who provide signed and dated written voluntary informed consent

Exclusion Criteria:

  1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are:

    • women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
    • women shoes partners have been sterilized by vasectomy or other means
    • two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
  2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
  3. Have previously received treatment with Targin or Oxycontin within 4weeks(28days) of screening periods(including PRN)
  4. If subjects started first cycle of chemotherapy during the 2 weeks before the screening visit or during the study, they should be excluded from the study.

    And If the chemotherapy regimen or dosage to be planned to change during the study, the subjects should be excluded from the study.

  5. Patient who is administered laxatives with stable dose for more than 1 week
  6. Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration. Any history of hypersensitivity to Oxycodone and Naloxone
  7. Patients with significant respiratory depression
  8. Patients with acute or severe bronchial asthma or hypercarbia
  9. Any patient who has or is suspected of having paralytic ileus
  10. Severe Chronic obstructive pulmonary disease, pulmonary heart disease
  11. Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
  12. Patients with moderate and severe hepatic impairment
  13. 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)
  14. Any situation where opioids are contraindicated
  15. Major surgery within 1 month prior to screening or planned surgery
  16. Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)
  17. 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
  18. Patients with uncontrolled seizures
  19. Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
  20. With a history of alcohol abuse within 6 months of screening
  21. With a history of illicit drug abuse within 6 months of screening
  22. Patients with increased intracranial pressure
  23. In the investigator's opinion, subjects who are receiving hypnotics or other central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication
  24. Patients with myxodema, not adequately treated hypothyroidism or Addison's disease
  25. Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine)
  26. Patients with evidence of clinically significant gastrointestinal disease (e.g. paralytic ileus, peritoneal carcinosis), significant structural abnormalities of the gastrointestinal tract (e.g. scarring, obstruction etc) either related or not related to the underlying cancer or disease progression
  27. Patients suffering from diarrhea and/or opioid withdrawal
  28. With a disability that may prevent the patient from completing all study requirements and in particular, interfere with 24hrs pain intensity score
  29. Clinically significant impairment of cardiovascular, respiratory and renal function
  30. Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
  31. Having used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313780

Contacts
Contact: Mundipharma Korea Ltd. +82 2 527 9218 Kr_Med@mundipharma.co.kr

Locations
Korea, Republic of
AMC Recruiting
Seoul, Pungnap-dong, Korea, Republic of, 138-736
Contact: Seonhwa Kim, Nurse         
Principal Investigator: Mundipharma Korea Ltd.         
Investigational Site Not yet recruiting
Seoul, Korea, Republic of
Contact: Mundipharma Korea Ltd.         
Principal Investigator: Mundipharma Korea Ltd.         
Sponsors and Collaborators
Mundipharma Pte Ltd.
Investigators
Principal Investigator: Kim, M.D Asan Medical Center
Principal Investigator: Ahn, M.D Samsung Medical Center
Principal Investigator: Kim, M.D National Cancer Center
Principal Investigator: Kim, M.D SMG-SNU Boramae Medical Center
Principal Investigator: Lee, M.D Shinchone Yonsei Severance Medical Center
Principal Investigator: Kang Jugnhoon Kyungsang University Hospital
Principal Investigator: Lee Kyunghee, MD Youngnam Univ. Hospital
Principal Investigator: Yoon Hwanjung, MD Chungnam University Hospital
  More Information

No publications provided

Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT01313780     History of Changes
Other Study ID Numbers: OXN10-KR-002
Study First Received: March 8, 2011
Last Updated: March 13, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Mundipharma Pte Ltd.:
cancer related pain

Additional relevant MeSH terms:
Naloxone
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 15, 2014