Trial Outcomes & Findings for A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain (NCT NCT01165281)
NCT ID: NCT01165281
Last Updated: 2017-07-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
343 participants
Primary outcome timeframe
Baseline, Last 3 Days of Study Drug Administration (4 weeks)
Results posted on
2017-07-21
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
172
|
|
Overall Study
COMPLETED
|
110
|
121
|
|
Overall Study
NOT COMPLETED
|
58
|
51
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
14
|
|
Overall Study
Death
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
8
|
1
|
|
Overall Study
Protocol Violation
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
7
|
|
Overall Study
Noncompliance with Study Drug
|
1
|
4
|
|
Overall Study
Progressive Disease
|
10
|
14
|
|
Overall Study
Other
|
6
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
Baseline characteristics by cohort
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=168 Participants
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=172 Participants
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.
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
111 participants
n=5 Participants
|
110 participants
n=7 Participants
|
221 participants
n=5 Participants
|
|
Region of Enrollment
Korea
|
57 participants
n=5 Participants
|
62 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Age Customized
<65 years
|
77 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Age Customized
>=65 years
|
91 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Last 3 Days of Study Drug Administration (4 weeks)Population: 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).
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.
Outcome measures
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=126 Participants
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=139 Participants
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.
|
|---|---|---|
|
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
|
-2.69 Scores on scale
Standard Deviation 2.223
|
-2.57 Scores on scale
Standard Deviation 2.027
|
SECONDARY outcome
Timeframe: Baseline, Endpoint of the 4-week Treatment PeriodPopulation: 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).
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.
Outcome measures
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=126 Participants
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=139 Participants
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.
|
|---|---|---|
|
Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories
Percentage "much improved" or "very much improved"
|
58.7 Percentage of Participants
|
50.4 Percentage of Participants
|
|
Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories
Percentage "much worse" or "very much worse"
|
4.0 Percentage of Participants
|
1.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=94 Participants
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=103 Participants
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.
|
|---|---|---|
|
Frequency of Rescue Medication Use for the Double-blind Treatment Period
|
1.39 Number of doses per day
Standard Deviation 0.460
|
1.35 Number of doses per day
Standard Deviation 0.431
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=94 Participants
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=103 Participants
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.
|
|---|---|---|
|
Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period
|
6.95 Milligrams
Standard Deviation 2.302
|
6.73 Milligrams
Standard Deviation 2.153
|
SECONDARY outcome
Timeframe: Baseline, Last 3 Days of Study Drug Administration (4 weeks)Population: 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).
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.
Outcome measures
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=126 Participants
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=139 Participants
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.
|
|---|---|---|
|
Proportion of Patients With Various Levels of Pain Improvement (Responders)
Proportion with at least a 30 percent improvement
|
63.5 Percentage of Participants
|
59.0 Percentage of Participants
|
|
Proportion of Patients With Various Levels of Pain Improvement (Responders)
Proportion with at least a 50 percent improvement
|
50.0 Percentage of Participants
|
42.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=126 Participants
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=139 Participants
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.
|
|---|---|---|
|
Proportion of Patients Entering the Maintenance Period
|
86 Percentage of Participants
|
80 Percentage of Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy.
Outcome measures
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=126 Participants
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=139 Participants
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.
|
|---|---|---|
|
Number of Patients Who Discontinued Due to Lack of Efficacy
|
1 Number of participants
|
0 Number of participants
|
Adverse Events
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
Serious events: 78 serious events
Other events: 110 other events
Deaths: 0 deaths
Oxycodone Controlled-release (CR) Oral Tablets
Serious events: 69 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=168 participants at risk
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=172 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.60%
1/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/168 • 4 weeks
|
1.2%
2/172 • 4 weeks
|
|
Gastrointestinal disorders
Ascites
|
2.4%
4/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
4/168 • 4 weeks
|
1.2%
2/172 • 4 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
2/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Ileus
|
0.60%
1/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
3/168 • 4 weeks
|
1.7%
3/172 • 4 weeks
|
|
General disorders
Asthenia
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
General disorders
Disease progression
|
23.8%
40/168 • 4 weeks
|
20.9%
36/172 • 4 weeks
|
|
General disorders
Drug interaction
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
General disorders
Fatigue
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
General disorders
Pyrexia
|
0.60%
1/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/168 • 4 weeks
|
1.7%
3/172 • 4 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.60%
1/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Infections and infestations
Abdominal abscess
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Infections and infestations
Oesophageal candidiasis
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Infections and infestations
Pneumonia
|
3.6%
6/168 • 4 weeks
|
3.5%
6/172 • 4 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.60%
1/168 • 4 weeks
|
1.2%
2/172 • 4 weeks
|
|
Infections and infestations
Pseudomembranous colitis
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Investigations
Biopsy lung
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Investigations
Neutrophil count decreased
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.2%
2/168 • 4 weeks
|
1.7%
3/172 • 4 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.60%
1/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.2%
2/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Nervous system disorders
Aphasia
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
2/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Nervous system disorders
Paralysis
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Psychiatric disorders
Delirium
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Renal and urinary disorders
Urethral stenosis
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.8%
3/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
2/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/168 • 4 weeks
|
0.58%
1/172 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
2/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
2/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.60%
1/168 • 4 weeks
|
0.00%
0/172 • 4 weeks
|
Other adverse events
| Measure |
Tapentadol (JNS024) Extended-release (ER) Oral Tablets
n=168 participants at risk
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.
|
Oxycodone Controlled-release (CR) Oral Tablets
n=172 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
4/168 • 4 weeks
|
6.4%
11/172 • 4 weeks
|
|
Gastrointestinal disorders
Constipation
|
30.4%
51/168 • 4 weeks
|
37.2%
64/172 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
9/168 • 4 weeks
|
11.0%
19/172 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
28.6%
48/168 • 4 weeks
|
35.5%
61/172 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
24.4%
41/168 • 4 weeks
|
23.8%
41/172 • 4 weeks
|
|
General disorders
Disease progression
|
8.3%
14/168 • 4 weeks
|
8.7%
15/172 • 4 weeks
|
|
General disorders
Malaise
|
3.6%
6/168 • 4 weeks
|
7.0%
12/172 • 4 weeks
|
|
General disorders
Pyrexia
|
6.0%
10/168 • 4 weeks
|
7.6%
13/172 • 4 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
21/168 • 4 weeks
|
14.0%
24/172 • 4 weeks
|
|
Nervous system disorders
Somnolence
|
17.3%
29/168 • 4 weeks
|
20.9%
36/172 • 4 weeks
|
|
Psychiatric disorders
Delirium
|
6.0%
10/168 • 4 weeks
|
3.5%
6/172 • 4 weeks
|
|
Psychiatric disorders
Insomnia
|
5.4%
9/168 • 4 weeks
|
6.4%
11/172 • 4 weeks
|
Additional Information
Medical Director
Janssen Pharm KK Japan
Phone: ＋81-3-5509
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER