CancerPhase 4NCT01675531
A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A Phase 4 study testing Targin in people with Cancer, run by Mundipharma Korea Ltd at 1 site in South Korea.
Trial summary
A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy) who need opioid combination treatment with existing pregabalin of last dose prior to study enrollment without changing. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Targin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to 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 ≥ 20 and <80 years of age
- Patients who has diagnosed as Chemotherapy-Induced Peripheral Neuropathy by investigator's judgment
- Patient who are receiving pregabalin for the treatment of Chemotherapy- Induced Peripheral Neuropathy
- Patients who have moderate to severe pain intensity which is not controlled with 300mg of pregabalin per day for at least 1 week: NRS ≥ 4
- Patients who need opioid combination treatment with existing pregabalin treatment
- Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)
- Patients who signed a written informed consent form
Who cannot join
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are:
- women whose 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 spermicidal. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or (Progest - progesterone) 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
- Patients with known hypersensitivity to Oxycodone or Naloxone or to any of the excipients
- Patients with severe respiratory depression with hypoxia and/or hypercapnia
Show all 29Show fewer
- Patients with severe chronic obstructive pulmonary disease
- Patients with cor pulmonale
- Patients with severe bronchial asthma
- Patients with non-opioid induced paralytic ileus
- Patients with moderate to severe hepatic impairment
- Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
- 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), gamma glutamyl transpeptidase (GGT or GGTP) ≥ 3 times the upper limit of normal
- Patients with uncontrolled seizures
- Requiring interventional treatment for pain such as neural blockade procedure or regional infusion
- 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)
- Clinically significant impairment of cardiovascular, respiratory and renal function
- Major surgery within 1 month prior to screening or planned surgery
- Chemotherapy or radiotherapy within 2 weeks prior to the screening visit, or planned chemotherapy or radiotherapy during the study period.
- Mainly pain originated other than Chemotherapy-Induced Peripheral Neuropathy
- Patients with diabetic neuropathy
- With a disability that may prevent the patient from completing all study requirements and in particular, interfere with 24hrs pain intensity score
- Patients known to have, or suspected of having a history of drug abuse
- Patients with history of opioid or drug dependence
- Any situation where opioids are contraindicated
- Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy Who Need Opioid Combination Treatment With Existing Pregabalin Treatment
A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy) who need opioid combination treatment with existing pregabalin of last dose prior to study enrollment without changing.
The investigators will assess study objectives as below.
Read more
Primary objective
- To assess the pain reduction rate after 4 weeks treatment from baseline (week 0)
Secondary objectives
- To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACIT-GOG/NTX)
- To assess physician's overall satisfaction
- To assess subject's overall satisfaction
- To assess safety
The investigators have a hypothesis that Targin will show favorable efficacy \& safety profile for CIPN patients.
Read the detailed description
This will be a multicenter, phase IV, interventional study to assess the efficacy and safety of Targin (Oxycodone/Naloxone) Korean patients with CIPN(Chemotherapy-Induced Peripheral Neuropathy) who need opioid combination treatment with existing pregabalin of last dose prior to study enrollment without changing.
Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety data (adverse event (AE)/serious adverse events (SAEs)) including laboratory results, physical examination, vital sign, medical history taking, 24 hours pain intensity score, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG/NTX), physician's overall satisfaction and subject's overall satisfaction. If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will receive treatment with Targin. Re-screening, study drug dose interruption is not allowed. The duration of study drug dose interruption is defined as for 1 week.
Treatment with Targin will be started at 10/5mg twice daily for 4 weeks, and proper titration (up-titration) will be allowed at each visit according to the investigator's decision. Dose titration up to a maximum of Targin 40/20mg twice daily will be permitted during study period.
The up-titration will be considered by investigator's judgement as followings; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average Numeric Rating Scale (NRS), if the NRS was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
Safety laboratories will be obtained at baseline (visit 1) and study end (visit 4) in a local laboratory. The laboratory values within 4 weeks prior to baseline (visit 1) will be allowed to use at study visit 1.
The rescue medication is the 5mg of (Immediate release codon trade mark)IRcodonTM .
Patients will be withdrawn from the study if the following circumstance require study drug discontinuation:
Failure of pain control (Failure of pain control will be decided by investigators judgement, e.g. there is poor pain control or lack of efficacy despite 2~3 times of up titration.) Adjustment of the other analgesics due to AEs except Targin or IRcodonTM Adjustment of the other major pain management modality (e.g. chemotherapy, radiotherapy, surgery, non-surgical interventional therapy, etc.) Withdrawal of informed consent Pregnancy Any other significant risk to the patient's safety in the clinical judgement of the investigator
- Conditions
- Cancer
- Being tested
- Targin
- Keywords
- Targin, Chemotherapy Induced Peripheral Neuropathy (CIPN)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarginDrug
Also called Oxycodone and Naloxone
Single arm for Targin
| Study group | Role | What they receive |
|---|---|---|
| Targin | Experimental | Targin Receives: Drug: Targin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (Numeric Rating Scale)
Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0).
NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline.
Measured: 4 weeks
Secondary outcomes (3)
Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FAICT-GOG/NTX).
The mean changes in FACT/GOG-NTX total score and each FACT/GOG-NTX subscale score from Visit 1 (Week 0) to Visit 4 (Week 4 post-treatment) were analyzed. Missing data was handled as LOCF(Last Observation Carried Forward Method).
FACT/GOG-NTX total score range was from 0 to 152. The average change score from baseline to visit 4 indicates thay a lower score on the FACT/GOG-NTX means lower quality of life and a greater impact of neurotoxic symptom on the patient's life.
Measured: 4 weeks
Physician's Overall Satisfaction
Physician's overall satisfaction was scored 7 scales from Very much worse to Very much improved. (Very much worse, much worse, minimally worse, No change, Minimally improved, much improved, very much improved).
Measured: 4 weeks
Patient's Overall Satisfaction
Patient's overall satisfaction was assessed 7 scales from very much worse to very much improved. (Very much worse, much worse, minimally worse, no change, minimally improved, much improved, very much improved)
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionDec 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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kang, Ph.D, Principal investigator, Seoul ST.Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675531
- Sponsor's protocol ID
- OXN12-KR-402
- Status last verified
- Oct 2016
- First submitted
- 27 Aug 2012
- Last updated
- 16 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy Who Need Opioid Combination Treatment With Existing Pregabalin Treatment
- ClinicalTrials.gov ID
- NCT01675531
- Acronym / sponsor ID
- OXN12-KR-402
- Conditions
- Cancer
- Keywords
- Targin, Chemotherapy Induced Peripheral Neuropathy (CIPN)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 16 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, phase IV, interventional study to assess the efficacy and safety of Targin (Oxycodone/Naloxone) Korean patients with CIPN (Chemotherapy-Induced Peripheral Neuropathy) who need opioid combination treatment with existing pregabalin of last dose prior to study enrollment without changing.
The investigators will assess study objectives as below.
Primary objective
- To assess the pain reduction rate after 4 weeks treatment from baseline (week 0)
Secondary objectives
- To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACIT-GOG/NTX)
- To assess physician's overall satisfaction
- To assess subject's overall satisfaction
- To assess safety
The investigators have a hypothesis that Targin will show favorable efficacy \& safety profile for CIPN patients.
Detailed description
This will be a multicenter, phase IV, interventional study to assess the efficacy and safety of Targin (Oxycodone/Naloxone) Korean patients with CIPN(Chemotherapy-Induced Peripheral Neuropathy) who need opioid combination treatment with existing pregabalin of last dose prior to study enrollment without changing.
Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety data (adverse event (AE)/serious adverse events (SAEs)) including laboratory results, physical examination, vital sign, medical history taking, 24 hours pain intensity score, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG/NTX), physician's overall satisfaction and subject's overall satisfaction. If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will receive treatment with Targin. Re-screening, study drug dose interruption is not allowed. The duration of study drug dose interruption is defined as for 1 week.
Treatment with Targin will be started at 10/5mg twice daily for 4 weeks, and proper titration (up-titration) will be allowed at each visit according to the investigator's decision. Dose titration up to a maximum of Targin 40/20mg twice daily will be permitted during study period.
The up-titration will be considered by investigator's judgement as followings; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average Numeric Rating Scale (NRS), if the NRS was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
Safety laboratories will be obtained at baseline (visit 1) and study end (visit 4) in a local laboratory. The laboratory values within 4 weeks prior to baseline (visit 1) will be allowed to use at study visit 1.
The rescue medication is the 5mg of (Immediate release codon trade mark)IRcodonTM .
Patients will be withdrawn from the study if the following circumstance require study drug discontinuation:
Failure of pain control (Failure of pain control will be decided by investigators judgement, e.g. there is poor pain control or lack of efficacy despite 2~3 times of up titration.) Adjustment of the other analgesics due to AEs except Targin or IRcodonTM Adjustment of the other major pain management modality (e.g. chemotherapy, radiotherapy, surgery, non-surgical interventional therapy, etc.) Withdrawal of informed consent Pregnancy Any other significant risk to the patient's safety in the clinical judgement of the investigator
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targin | Experimental | Drug: TarginTargin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ 20 and <80 years of age
- Patients who has diagnosed as Chemotherapy-Induced Peripheral Neuropathy by investigator's judgment
- Patient who are receiving pregabalin for the treatment of Chemotherapy- Induced Peripheral Neuropathy
- Patients who have moderate to severe pain intensity which is not controlled with 300mg of pregabalin per day for at least 1 week: NRS ≥ 4
- Patients who need opioid combination treatment with existing pregabalin treatment
Key exclusion criteria (29 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
- Patients with known hypersensitivity to Oxycodone or Naloxone or to any of the excipients
- Patients with severe respiratory depression with hypoxia and/or hypercapnia
- Patients with severe chronic obstructive pulmonary disease
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 |
|---|---|---|
| TarginAlso: Oxycodone and NaloxoneSingle arm for Targin | Drug | Targin |
Primary outcome
NRS (Numeric Rating Scale)
Time frame: 4 weeks
Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0). NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline.
3 secondary outcomes
Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).
Time frame: 4 weeks
Physician's Overall Satisfaction
Time frame: 4 weeks
Patient's Overall Satisfaction
Time frame: 4weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kang, Ph.D principal investigator
Seoul ST.Mary Hospital
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 Targin 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 7 inclusion and 29 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 16 Dec 2016. 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 16 Dec 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?
NRS (Numeric Rating Scale) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2016; AzTrials last refreshed its copy on 6 Nov 2026.