CancerPhase 4TOPNCT01313780
A Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone Compared to OxyContin in Korean Cancer Patients
A Phase 4 study testing Oxycodone/Naloxone and Oxycodone(single compound) in people with Cancer, run by Mundipharma Korea Ltd at 1 site in South Korea.
Trial summary
Objectives: To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity 1. Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks 2. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Oxycodone/Naloxone and Oxycodone(single compound)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 35Show fewer
- 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
- Patients with moderate and severe hepatic impairment
- 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)
- Any situation where opioids are contraindicated
- Major surgery within 1 month prior to screening or planned surgery
- Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)
- 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
- Patients with uncontrolled seizures
- Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
- With a history of alcohol abuse within 6 months of screening
- With a history of illicit drug abuse within 6 months of screening
- Patients with increased intracranial pressure
- 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
- Patients with myxoedema, not adequately treated hypothyroidism or Addison's disease
- Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine)
- 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
- Patients suffering from diarrhea and/or opioid withdrawal
- With a disability that may prevent the patient from completing all study requirements and in particular, interfere with 24hrs pain intensity score
- Clinically significant impairment of cardiovascular, respiratory and renal function
- Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
- Having used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
Trial locations and contacts
1 site in 1 country.
About this study
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)
Objectives:
To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity
- Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks
- 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
Read the 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.
- Conditions
- Cancer
- Being tested
- Oxycodone/Naloxone, Oxycodone(single compound)
- Keywords
- cancer related pain
- Medical subject headings
- Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone/NaloxoneDrug
Also called Targin(fixed combination drug)
Dose and administration : Upto 40mg B.I.D per daily.
Oxycodone(single compound)Drug
Also called Oxycontin
Dose and administration : Upto 40mg B.I.D per daily.
| Study group | Role | What they receive |
|---|---|---|
| 'Oxycodone/Naloxone' | Experimental | Trade name is Targin(fixed combination drug). Receives: Drug: Oxycodone/Naloxone |
| Oxycodone | Active comparator | Trade name is Oxycontin(single compound). Receives: Drug: Oxycodone(single compound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 4weeks
Secondary outcomes (1)
Change in Bowel Habits.
The change of bowel habits from baseline (Visit 1) in bowel habits at Week 4 was investigated, and was categorized as 'improved', 'unchanged', and 'worsened'.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim, M.D, Principal investigator, Asan Medical CenterAhn, M.D, Principal investigator, Samsung Medical CenterKim, M.D, Principal investigator, National Cancer CenterKim, M.D, Principal investigator, SMG-SNU Boramae Medical CenterLee, M.D, Principal investigator, Shinchone Yonsei Severance Medical CenterKang Jugnhoon, Principal investigator, Kyungsang University HospitalLee Kyunghee, MD, Principal investigator, Youngnam Univ. HospitalYoon Hwanjung, MD, Principal investigator, Chungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313780
- Sponsor's protocol ID
- OXN10-KR-002
- Acronym
- TOP
- Status last verified
- Nov 2017
- First submitted
- 8 Mar 2011
- Last updated
- 22 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28893309
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01313780
- Acronym / sponsor ID
- TOP / OXN10-KR-002
- Conditions
- Cancer
- Keywords
- cancer related pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Posted 27 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
To prove non-inferiority of Targin compared to Oxycontin in terms of change of pain intensity
- Primary objective: Change of pain intensity (NRS 0-10) score (average pain over 24 hours obtained each evening) within 4 weeks
- 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Oxycodone/Naloxone' | Experimental | Drug: Oxycodone/NaloxoneTrade name is Targin(fixed combination drug). |
| Oxycodone | Active comparator | Drug: Oxycodone(single compound)Trade name is Oxycontin(single compound). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (35 listed)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone/NaloxoneAlso: Targin(fixed combination drug)Dose and administration : Upto 40mg B.I.D per daily. | Drug | 'Oxycodone/Naloxone' |
| Oxycodone(single compound)Also: OxycontinDose and administration : Upto 40mg B.I.D per daily. | Drug | Oxycodone |
Primary outcome
Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)
Time frame: 4weeks
Change of pain intensity from 0(No pain) to 10(worst pain imaginable) after 4 weeks treatment .
1 secondary outcome
Change in Bowel Habits.
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28893309Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim, M.D principal investigator
Asan Medical Center
Ahn, M.D principal investigator
Samsung Medical Center
Kim, M.D principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone/Naloxone and Oxycodone(single compound) in people with Cancer, run by Mundipharma Korea Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3) (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01313780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.