Cancer
Conditions
Keywords
Targin, Cancer Pain
Brief summary
The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under conditions of daily practice.
Detailed description
An open-label, multi-center, nonrandomized, prospective, non-interventional, observational phase IV trial. At the first visit, a detailed medical history is taken, including previous analgesics and concomitant treatment. After inclusion, patients enter a 4-week observation period during which they will receive bid of TARGIN 10/5mg and/or 20/10mg. The dose adjustments of TARGIN as well as of analgesic co-medication, rescue-medication and other treatments (e.g. laxatives) can be performed at any time-point during the observation period by the physician in dependence of medical demand. The asymmetric dose is allowed during the observation period by the physician's judgment. (e.g. 10/5 mg in the morning and 20/10 mg in the evening). Data are gathered using interview-administered questionnaires at baseline (visit 1) and study end (visit 2). During the observation period, unscheduled visits are allowed after the first visit due to inadequate pain control or occurrence of adverse events.
Interventions
Twice daily
Sponsors
Mundipharma Korea Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 (Only except occasional PRN) within 13 months or patients who has been on weak opioids 5. Ability to communicate effectively with the study personnel regarding pain intensity, constipation assessment, final assessment of overall efficacy and tolerability 6. Subject who provide signed and dated written voluntary informed consent
Exclusion criteria
1. Pregnant or nursing (lactating) women 2. Have previously received treatment with Targin 3. Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration 4. Any history of hypersensitivity to Oxycodone and Naloxone or any excipients 5. Patients with significant respiratory depression 6. Patients with acute or severe bronchial asthma or hypercarbia 7. Any patient who has or is suspected of having paralytic ileus 8. Severe Chronic obstructive pulmonary disease, pulmonary heart disease 9. Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take 10. Patients with moderate and severe hepatic impairment 11. 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) 12. Any situation where opioids are contraindicated 13. With a life expectancy \< 1 month 14. Any situation where opioids are contraindicated 15. Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy) 16. 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 17. Patients with uncontrolled seizures 18. Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion 19. With a history of alcohol abuse within 6 months of screening 20. With a history of illicit drug abuse within 6 months of screening 21. Patients with increased intracranial pressure 22. Having used other investigational drugs at the time of enrollment, or within 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numeric Rating Scales (NRS) Score | 4 weeks | Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Eastern Cooperative Oncology Group(ECOG) Performance Status | 4weeks | If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse. ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death. |
| Change of Constipation Assessment From Baseline to Visit 2(End Visit) | 4 weeks | Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms) |
| Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | 4 weeks | The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad. |
Countries
South Korea
Participant flow
Recruitment details
Safety set: 359 ITT set: 304
Participants by arm
| Arm | Count |
|---|---|
| Oxycodone/Naloxone Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
Oxycodone/Naloxone: Twice daily | 359 |
| Total | 359 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 38 |
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | well controlled pain | 27 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | Oxycodone/Naloxone |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 180 Participants |
| Age, Categorical Between 18 and 65 years | 179 Participants |
| Age, Continuous | 67.73 years STANDARD_DEVIATION 11.07 |
| Region of Enrollment Korea, Republic of | 359 participants |
| Sex: Female, Male Female | 134 Participants |
| Sex: Female, Male Male | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 227 / 359 |
| serious Total, serious adverse events | 51 / 359 |
Outcome results
Primary
Change in Numeric Rating Scales (NRS) Score
Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).
Time frame: 4 weeks
Population: Intent to treat analysis set: 304
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone/Naloxone | Change in Numeric Rating Scales (NRS) Score | -1.89 units on a scale | Standard Deviation 2.16 |
Secondary
Change of Constipation Assessment From Baseline to Visit 2(End Visit)
Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)
Time frame: 4 weeks
Population: Intent to treat analysis set(Last observational carried forward)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone/Naloxone | Change of Constipation Assessment From Baseline to Visit 2(End Visit) | -0.03 score | Standard Deviation 0.67 |
Secondary
Change of Eastern Cooperative Oncology Group(ECOG) Performance Status
If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse. ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death.
Time frame: 4weeks
Population: Intent to treat analysis set: 304
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxycodone/Naloxone | Change of Eastern Cooperative Oncology Group(ECOG) Performance Status | 0.08 Score | Standard Deviation 0.52 |
Secondary
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.
Time frame: 4 weeks
Population: Intent to treat analysis set(Last observational carried forward)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oxycodone/Naloxone | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Good | 80 participants |
| Oxycodone/Naloxone | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Bad | 53 participants |
| Oxycodone/Naloxone | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Satisfactory | 146 participants |
| Oxycodone/Naloxone | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Very Bad | 1 participants |
| Oxycodone/Naloxone | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Very good | 24 participants |
| Subject | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Very Bad | 3 participants |
| Subject | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Very good | 12 participants |
| Subject | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Good | 78 participants |
| Subject | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Satisfactory | 156 participants |
| Subject | Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject | Bad | 55 participants |