Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JNS024ER-KAJ-C02 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean patients with chronic, malignant, tumor-related cancer pain.
This is a randomized (study drug assigned by chance), double-blind (neither the patient nor the study staff will know the identity of the study drug assigned to each patient), multicenter study to evaluate the safety and efficacy of orally (by mouth) administered R331333 (referred to as JNS024 extended release [ER] capsules or CG5503) in dosages of 25 mg to 200 mg twice daily compared with orally administered capsules of oxycodone controlled release (CR) in dosages of 5 mg to 40 mg twice daily over 4 weeks in Japanese and Korean patients with moderate to severe chronic malignant tumor-related cancer pain who require around-the-clock opioid therapy (treatment with narcotic analgesics or pain relievers) and are dissatisfied with the pain relief they are experiencing from current treatment. The active control, oxycodone CR, is being used in this study because it is an opioid analgesic approved for the treatment of moderate to severe pain. Approximately 212 Japanese patients and approximately 100 Korean patients who meet screening criteria for the study will be enrolled in the study and will enter the titration period of the study where they will receive a starting dosage of either JNS024 ER 25 mg twice daily or oxycodone CR 5 mg twice daily. The dose of study drug for each patient will be titrated (increased) to the optimal dose until sufficient analgesia (pain relief) is achieved (ie, up to a maximum dose of JNS024 ER 200 mg twice daily or Oxycodone CR 40 mg twice daily). When the dosage of study drug is increased, the safety will be confirmed at the study visit or by telephone on the day after the dose is increased. Once an optimal dose of study drug is determined, the patient will continue to receive that dose during the maintenance period in the study. Patients will participate in the study for total of approximately 6 weeks; during this time patients will receive study drug for 4 weeks (titration and maintenance periods combined). During the study, if a patient experiences breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) will be given. In addition, patients will be allowed to continue to take stable doses of non-opioid analgesics (non-narcotic pain medications for mild to moderate pain) that they were taking at the time of study entry and may reduce the dosage or discontinue their use during the study. During the study, blood samples will be collected from patients at protocol-specified time points to determine the concentration of study drug after administration. The safety of patients will be monitored during the study by evaluating adverse events and findings from clinical laboratory tests, physical examinations, vital signs measurements, and electrocardiogram (ECG) measurements reported. The primary outcome measure in the study will be the change from baseline to the last 3 days of study drug administration in the average pain intensity score using an 11 point numerical rating scale (NRS). Patients will receive R331333 (referred to as JNS024 ER or CG5503) by mouth with or without food at a starting dose of 25 mg twice daily to be increased if necessary to a maximum dose of 200 mg twice daily for a total of 4 weeks (titration and maintenance periods combined) OR double-blind oxycodone CR by mouth with or without food at a starting dose of 5 mg twice daily to be increased if necessary to a maximum dose of 40 mg twice daily for a total of 4 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | R331333 (referred to as JNS024 ER or CG5503) One 25 mg to 200 mg capsule twice daily for 4 weeks. |
|
| 002 | Active Comparator | Oxycodone CR One 5 mg to 40 mg capsule twice daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone CR | Drug | One 5 mg to 40 mg capsule twice daily for 4 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale | The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: "What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine." The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration. | Baseline, Last 3 Days of Study Drug Administration (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories | The PGIC was rated by the patient and was based on the single question "Since the start of this treatment, my cancer-related pain overall is," where 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, 7=very much worse. | Baseline, Endpoint of the 4-week Treatment Period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23937387 | Derived | Imanaka K, Tominaga Y, Etropolski M, van Hove I, Ohsaka M, Wanibe M, Hirose K, Matsumura T. Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain. Curr Med Res Opin. 2013 Oct;29(10):1399-409. doi: 10.1185/03007995.2013.831816. Epub 2013 Aug 23. |
Not provided
Not provided
Not provided
To evaluate the safety and efficacy of tapentadol ER compared with oxycodone CR in Japanese and Korean patients with moderate to severe chronic cancer pain. This study was conducted from 25 Aug 2010 to 16 Aug 2012 at 69 sites in Japan and Korea. A total of 340 patients received at least 1 dose of study drug and were included in the safety analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| R331333 (referred to as JNS024 ER or CG5503) |
| Drug |
One 25 mg to 200 mg capsule twice daily for 4 weeks. |
|
| Frequency of Rescue Medication Use for the Double-blind Treatment Period | During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average number of doses of Morphine IR taken per day was assessed. | 4 weeks |
| Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period | During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average total daily dose of Morphine IR taken (mg) was assessed. | 4 weeks |
| Proportion of Patients With Various Levels of Pain Improvement (Responders) | The proportion of patients with at least a 30 percentage improvement based on the percent change from baseline in Numerical Rating Scale score during the last 3 days of the double-blind treatment period. | Baseline, Last 3 Days of Study Drug Administration (4 weeks) |
| Proportion of Patients Entering the Maintenance Period | Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. | 4 weeks |
| Number of Patients Who Discontinued Due to Lack of Efficacy | The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy. | 4 weeks |
| Fukui |
| Japan |
| Fukushima | Japan |
| Fukuyama | Japan |
| Fushimi | Japan |
| Hamamatsu | Japan |
| Hirosaki | Japan |
| Hitachi | Japan |
| Itami | Japan |
| Iwakuni | Japan |
| Izumo | Japan |
| Kamogawa | Japan |
| Kanuma | Japan |
| Kobe | Japan |
| Kumagaya | Japan |
| Kumamoto | Japan |
| Kure | Japan |
| Kyoto | Japan |
| Matsumoto | Japan |
| Matsusaka | Japan |
| Miyazaki | Japan |
| Nagoya | Japan |
| Natori | Japan |
| Niigata | Japan |
| Ogōri | Japan |
| Ohta | Japan |
| Okayama | Japan |
| Osaka | Japan |
| Saga | Japan |
| Saku | Japan |
| Sapporo | Japan |
| Sendai | Japan |
| Sunto | Japan |
| Takarazuka | Japan |
| Takasaki | Japan |
| Tokyo | Japan |
| Tomakomai | Japan |
| Toyama | Japan |
| Toyonaka | Japan |
| Ube | Japan |
| Yamagata | Japan |
| Yamanashi | Japan |
| Yokohama | Japan |
| Busan | South Korea |
| Chungcheongbuk-Do | South Korea |
| Daegu | South Korea |
| Deajun | South Korea |
| Gyeonggi-do | South Korea |
| Incheon | South Korea |
| Jinju | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| FG001 | Oxycodone Controlled-release (CR) Oral Tablets | Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
| BG001 | Oxycodone Controlled-release (CR) Oral Tablets | Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Age Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale | The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: "What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine." The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration. | Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation). | Posted | Mean | Standard Deviation | Scores on scale | Baseline, Last 3 Days of Study Drug Administration (4 weeks) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories | The PGIC was rated by the patient and was based on the single question "Since the start of this treatment, my cancer-related pain overall is," where 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, 7=very much worse. | Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation). | Posted | Number | Percentage of Participants | Baseline, Endpoint of the 4-week Treatment Period |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Frequency of Rescue Medication Use for the Double-blind Treatment Period | During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average number of doses of Morphine IR taken per day was assessed. | This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations. | Posted | Mean | Standard Deviation | Number of doses per day | 4 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period | During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average total daily dose of Morphine IR taken (mg) was assessed. | This is a subset of the per-protocol population that included patients who received at least 1 dose of rescue medication. The per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations. | Posted | Mean | Standard Deviation | Milligrams | 4 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Various Levels of Pain Improvement (Responders) | The proportion of patients with at least a 30 percentage improvement based on the percent change from baseline in Numerical Rating Scale score during the last 3 days of the double-blind treatment period. | Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation). | Posted | Number | Percentage of Participants | Baseline, Last 3 Days of Study Drug Administration (4 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Entering the Maintenance Period | Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. | Per-protocol population included all patients who were randomized, received at least 1 dose of study drug, had post-baseline efficacy data and didn't have major protocol deviations (including use of prohibited concomitant medications, non-compliance, failure to meet selection criteria, violation of regulatory requirements, or treatment deviation). | Posted | Number | Percentage of Participants | 4 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Discontinued Due to Lack of Efficacy | The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy. | Time to discontinuation due to lack of efficacy was not analyzed since there was only 1 patient in the per-protocol set (in the tapentadol group) who discontinued treatment due to lack of efficacy. | Posted | Number | Number of participants | 4 weeks |
|
4 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tapentadol (JNS024) Extended-release (ER) Oral Tablets | Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. | 78 | 168 | 110 | 168 | ||
| EG001 | Oxycodone Controlled-release (CR) Oral Tablets | Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. | 69 | 172 | 127 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Rectal ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Drug interaction | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Biopsy lung | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Janssen Pharm KK Japan | ＋81-3-5509 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D000077432 | Tapentadol |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Korea |
|
| >=65 years |
|
| Non-Inferiority or Equivalence |
In order to demonstrate that the upper limit of the confidence interval of intergroup differences in change from baseline is not higher than the noninferiority margin of 1 with a 1-tailed significance level of 0.025 and 90% power, the sample size was calculated to be 133 patients in each group for a total of 266 patients. Assuming approximately 20% of patients would be excluded from the analyses, the target sample size was 330 patients. |
| OG001 | Oxycodone Controlled-release (CR) Oral Tablets | Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
|
|
| OG001 | Oxycodone Controlled-release (CR) Oral Tablets | Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
|
|
| OG001 |
| Oxycodone Controlled-release (CR) Oral Tablets |
Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
|
|
| OG001 |
| Oxycodone Controlled-release (CR) Oral Tablets |
Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
|
|
| OG001 |
| Oxycodone Controlled-release (CR) Oral Tablets |
Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual's optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged. |
|
|
|
|