Back to resultsA Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Primary Purpose
Cancer
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Targin
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring Targin, Chemotherapy Induced Peripheral Neuropathy (CIPN)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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
Sites / Locations
- Seoul ST.Mary Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Targin
Arm Description
Targin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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)
Full Information
NCT ID
NCT01675531
First Posted
August 27, 2012
Last Updated
October 25, 2016
Sponsor
Mundipharma Korea Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01675531
Brief Title
A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Targin, Chemotherapy Induced Peripheral Neuropathy (CIPN)
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targin
Arm Type
Experimental
Arm Description
Targin
Intervention Type
Drug
Intervention Name(s)
Targin
Other Intervention Name(s)
Oxycodone and Naloxone
Intervention Description
Single arm for Targin
Primary Outcome Measure Information:
Title
NRS (Numeric Rating Scale)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).
Description
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.
Time Frame
4 weeks
Title
Physician's Overall Satisfaction
Description
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).
Time Frame
4 weeks
Title
Patient's Overall Satisfaction
Description
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)
Time Frame
4weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang, Ph.D
Organizational Affiliation
Seoul ST.Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul ST.Mary Hospital
City
Seoul
State/Province
Banpogu
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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