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

NCT01313780 | Completed Phase 4 Results

• 1 other identifier: OXN10-KR-002
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity

1. 1.Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks
2. 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

Conditions

Cancer

Keywords

cancer related pain

Outcome Measures

Primary Outcomes (1)

• Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)

  Change of pain intensity from 0(No pain) to 10(worst pain imaginable) after 4 weeks treatment .

  4weeks

Secondary Outcomes (1)

• Change in Bowel Habits.

  4 weeks

Study Arms (2)

'Oxycodone/Naloxone'

EXPERIMENTAL

Trade name is Targin(fixed combination drug).

Drug: Oxycodone/Naloxone

Oxycodone

ACTIVE COMPARATOR

Trade name is Oxycontin(single compound).

Drug: Oxycodone(single compound)

Interventions

Oxycodone/Naloxone DRUG

Dose and administration : Upto 40mg B.I.D per daily.

Also known as: Targin(fixed combination drug)

'Oxycodone/Naloxone'

Oxycodone(single compound) DRUG

Dose and administration : Upto 40mg B.I.D per daily.

Also known as: Oxycontin

Oxycodone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female cancer patients 20 years of age or older
• Cancer related pain that requires treatment with continuous around-the-clock strong opioid analgesic
• Moderate to severe pain intensity(NRS pain score 4)
• Opioid naïve patients or patients not treated with strong opioids(except PRN) within 4 weeks or patients who has been on weak opioids
• Subject who provide signed and dated written voluntary informed consent

You may not qualify if:

• 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.
• 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.
• Have previously received treatment with Targin or Oxycontin within 4weeks(28days) of screening periods(including PRN)
• 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.
• Patient who is administered laxatives with stable dose for more than 1 week
• 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
• Patients with significant respiratory depression
• Patients with acute or severe bronchial asthma or hypercarbia
• Any patient who has or is suspected of having paralytic ileus
• Severe Chronic obstructive pulmonary disease, pulmonary heart disease
• Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Study Sites (1)

AMC

Seoul, Pungnap-dong, 138-736, South Korea

Location

Related Publications (1)

• Lee KH, Kim TW, Kang JH, Kim JS, Ahn JS, Kim SY, Yun HJ, Eum YJ, Koh SA, Kim MK, Hong YS, Kim JE, Lee GW. Efficacy and safety of controlled-release oxycodone/naloxone versus controlled-release oxycodone in Korean patients with cancer-related pain: a randomized controlled trial. Chin J Cancer. 2017 Sep 11;36(1):74. doi: 10.1186/s40880-017-0241-4.

  PMID: 28893309 DERIVED

MeSH Terms

Conditions

Neoplasms; Cancer Pain

Interventions

Oxycodone; Naloxone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Taewon Kim
• Organization: Seoul Asan Hospital

twkimmd@amc.seoul.kr

82-2-3010-3910

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 14, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2014
• Last Updated: December 22, 2017
• Results First Posted: October 27, 2016

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)