Trial Outcomes & Findings for A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia (NCT NCT01124617)

Last Updated: 2014-01-13

Results Overview

Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

91 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2014-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Tapentadol Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Overall Study STARTED	60	31
Overall Study COMPLETED	41	25
Overall Study NOT COMPLETED	19	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Tapentadol Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Overall Study Adverse Event	5	2
Overall Study Lack of Efficacy	2	1
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	9	1
Overall Study Other	2	1

Baseline Characteristics

A Phase 2 Study of Tapentadol Extended-Release (JNS024ER) ) in Japanese Participants With Chronic Pain Due to Diabetic Neuropathic Pain or Postherpetic Neuralgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.	Total n=91 Participants Total of all reporting groups
Age, Continuous	64.6 Years STANDARD_DEVIATION 12.98 • n=5 Participants	68.6 Years STANDARD_DEVIATION 11.60 • n=7 Participants	65.9 Years STANDARD_DEVIATION 12.61 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	14 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	17 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 Baseline	6.7 Units on a scale Standard Deviation 1.15	6.9 Units on a scale Standard Deviation 1.35
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 Change at Week 12	-2.6 Units on a scale Standard Deviation 2.23	-2.6 Units on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11

Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 1	-0.7 Units on a scale Standard Deviation 1.15	-0.2 Units on a scale Standard Deviation 0.52
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 2	-1.1 Units on a scale Standard Deviation 1.47	-0.9 Units on a scale Standard Deviation 1.47
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 3	-1.5 Units on a scale Standard Deviation 1.75	-1.1 Units on a scale Standard Deviation 1.59
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 4	-1.8 Units on a scale Standard Deviation 1.88	-1.6 Units on a scale Standard Deviation 1.78
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 5	-2.1 Units on a scale Standard Deviation 1.87	-1.7 Units on a scale Standard Deviation 2.09
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 6	-2.3 Units on a scale Standard Deviation 1.97	-2.0 Units on a scale Standard Deviation 2.41
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 7	-2.3 Units on a scale Standard Deviation 2.10	-2.2 Units on a scale Standard Deviation 2.55
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 8	-2.4 Units on a scale Standard Deviation 2.12	-2.4 Units on a scale Standard Deviation 2.50
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 9	-2.5 Units on a scale Standard Deviation 2.20	-2.4 Units on a scale Standard Deviation 2.56
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 10	-2.6 Units on a scale Standard Deviation 2.22	-2.6 Units on a scale Standard Deviation 2.51
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 Change at Week 11	-2.6 Units on a scale Standard Deviation 2.25	-2.4 Units on a scale Standard Deviation 2.66

SECONDARY outcome

Timeframe: Week 12

Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.

Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) Greater than or equal to 30% treatment response	48.3 Percentage of participants	41.9 Percentage of participants
Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) Greater than or equal to 50% treatment response	33.3 Percentage of participants	38.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 8 and Week 12

Population: FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points.

The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.

Outcome measures

Outcome measures
Measure	Tapentadol n=46 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=26 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 8: Very Much Improved (n = 46, 26)	7 Participants	4 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 8: Much Improved (n = 46, 26)	16 Participants	7 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 8: Minimally Improved (n = 46, 26)	16 Participants	10 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 8: No Change (n = 46, 26)	6 Participants	2 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 8: Minimally Worse (n = 46, 26)	1 Participants	2 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 8: Much Worse (n = 46, 26)	1 Participants	1 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 8: Very Much Worse (n = 46, 26)	0 Participants	0 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 12: Very Much Improved (n = 40, 25)	6 Participants	2 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 12 : Much Improved (n = 40, 25)	18 Participants	9 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 12 : Minimally Improved (n = 40, 25)	13 Participants	11 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 12 : No Change (n = 40, 25)	2 Participants	2 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 12 : Minimally Worse (n = 40, 25)	0 Participants	0 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 12 : Much Worse (n = 40, 25)	1 Participants	1 Participants
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale Week 12 : Very Much Worse (n = 40, 25)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 8 and Week 12

Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "ineffective".

Outcome measures

Outcome measures
Measure	Tapentadol n=46 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=26 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Number of Participants With Categorical Scores on Physician's Global Assessment Scale Week 12: Effective (n = 40, 25)	35 Participants	20 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment Scale Week 8: Effective (n = 46, 26)	41 Participants	19 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment Scale Week 8: Ineffective (n = 46, 26)	5 Participants	7 Participants
Number of Participants With Categorical Scores on Physician's Global Assessment Scale Week 12 : Ineffective (n = 40, 25)	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.

The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale Baseline (n=60, 31)	4.7 Units on a scale Standard Deviation 2.13	4.6 Units on a scale Standard Deviation 2.20
Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale Week 12 (n=25,40)	-2.6 Units on a scale Standard Deviation 1.92	-2.1 Units on a scale Standard Deviation 2.48

SECONDARY outcome

Timeframe: Baseline and Week 12

The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent \[no pain\]) to 10 (extreme \[pain as bad as you can image\]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale Baseline (n=60, 31)	6.2 Units on a scale Standard Deviation 1.19	6.3 Units on a scale Standard Deviation 1.22
Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale Week 12 (n=25,40)	-3.0 Units on a scale Standard Deviation 1.72	-2.6 Units on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.

The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 Baseline (n=60,31)	5.2 Units on a scale Standard Deviation 1.58	5.2 Units on a scale Standard Deviation 1.52
Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 Change at Week 12 (n=40,25)	-2.7 Units on a scale Standard Deviation 1.64	-2.3 Units on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Baseline and Week 12

Sleep Latency was related to "How long after bedtime or lights out did the participant fall asleep last night ". Decrease in time indicates an improvement.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=30 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 Baseline (n=60, 30)	45.4 Minutes Standard Deviation 65.78	34.7 Minutes Standard Deviation 28.62
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 Change at Week 12 (n=40, 24)	-11.1 Minutes Standard Deviation 49.15	-3.1 Minutes Standard Deviation 30.17

SECONDARY outcome

Timeframe: Baseline and Week 12

Time slept was related to "How long did the participant sleep last night". The mean change for the time in hours slept during the last night was reported.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 Baseline (n=60, 31)	5.8 Hours Standard Deviation 1.29	6.4 Hours Standard Deviation 1.97
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 Change at Week 12 (n=40,25)	0.3 Hours Standard Deviation 1.71	0.3 Hours Standard Deviation 1.58

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.

Number of awakenings was related to "How many times did the participant wake up during the night". Lesser number signifies better sleep.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=30 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Number of Participants With Awakenings Based on Sleep Questionnaire Baseline: 0 awakening (n=60,30)	17 Participants	3 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Baseline: 1 awakening (n=60,30)	16 Participants	9 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Baseline: 2 awakenings (n=60,30)	10 Participants	10 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Baseline: 3 awakenings (n=60,30)	8 Participants	6 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Baseline: 4 awakenings (n=60,30)	5 Participants	1 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Baseline: > or = 5 awakenings (n=60,30)	4 Participants	1 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Week 12 : 0 awakening (n=40,25)	12 Participants	3 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Week 12 : 1 awakening (n=40,25)	14 Participants	8 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Week 12 : 2 awakenings (n=40,25)	9 Participants	7 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Week 12 : 3 awakenings (n=40,25)	1 Participants	4 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Week 12 : 4 awakenings (n=40,25)	3 Participants	2 Participants
Number of Participants With Awakenings Based on Sleep Questionnaire Week 12 : > or = 5 awakenings (n=40,25)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Participants rated the overall quality of sleep last night as excellent, good, fair and poor.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire Week 12 : Good (n=40,25)	28 Participants	17 Participants
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire Baseline: Excellent (n=60,31)	0 Participants	1 Participants
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire Baseline: Good (n=60,31)	35 Participants	12 Participants
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire Baseline: Fair (n=60,31)	22 Participants	16 Participants
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire Baseline: Poor (n=60,31)	3 Participants	2 Participants
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire Week 12 : Excellent (n=60,31)	4 Participants	0 Participants
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire Week 12 : Fair (n=40,25)	6 Participants	8 Participants
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire Week 12 : Poor (n=40,25)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.

Outcome measures

Outcome measures
Measure	Tapentadol n=60 Participants Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 Participants Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Physical Functioning: Baseline (n=60,31)	68.6 Units on a scale Standard Deviation 21.88	61.0 Units on a scale Standard Deviation 24.20
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Role-Physical: Baseline (n=60,31)	70.1 Units on a scale Standard Deviation 27.95	64.3 Units on a scale Standard Deviation 28.15
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Bodily Pain: Baseline (n=60,31)	36.2 Units on a scale Standard Deviation 16.74	38.8 Units on a scale Standard Deviation 14.50
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 General Health: Baseline (n=60,31)	45.7 Units on a scale Standard Deviation 16.73	44.7 Units on a scale Standard Deviation 17.51
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Vitality: Baseline (n=60,31)	48.8 Units on a scale Standard Deviation 23.49	50.4 Units on a scale Standard Deviation 22.47
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Social Functioning: Baseline (n=60,31)	72.9 Units on a scale Standard Deviation 26.66	80.2 Units on a scale Standard Deviation 27.72
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Role-Emotional: Baseline (n=60,31)	68.9 Units on a scale Standard Deviation 30.91	68.5 Units on a scale Standard Deviation 28.19
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Mental Health: Baseline (n=60,31)	57.6 Units on a scale Standard Deviation 24.54	61.8 Units on a scale Standard Deviation 22.04
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Mental Summary: Baseline (n=60,31)	43.9 Units on a scale Standard Deviation 12.27	47.6 Units on a scale Standard Deviation 10.65
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Physical Summary: Baseline (n=60,31)	36.0 Units on a scale Standard Deviation 16.11	31.7 Units on a scale Standard Deviation 16.48
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Physical Functioning: Change at Week 12 (n=40,25)	5.4 Units on a scale Standard Deviation 13.65	4.8 Units on a scale Standard Deviation 14.89
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Role-Physical: Change at Week 12 (n=40,25)	6.6 Units on a scale Standard Deviation 21.74	4.8 Units on a scale Standard Deviation 22.26
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Bodily Pain: Change at Week 12 (n=40,25)	10.5 Units on a scale Standard Deviation 15.43	7.0 Units on a scale Standard Deviation 15.57
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 General Health: Change at Week 12 (n=40,25)	-0.4 Units on a scale Standard Deviation 10.74	0.2 Units on a scale Standard Deviation 11.83
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Vitality: Change at Week 12 (n=40,25)	9.4 Units on a scale Standard Deviation 19.09	6.8 Units on a scale Standard Deviation 22.31
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Social Functioning: Change at Week 12 (n=40,25)	8.1 Units on a scale Standard Deviation 21.47	2.0 Units on a scale Standard Deviation 37.27
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Role-Emotional: Change at Week 12 (n=40,25)	6.0 Units on a scale Standard Deviation 27.02	5.7 Units on a scale Standard Deviation 25.65
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Mental Health: Change at Week 12 (n=40,25)	7.8 Units on a scale Standard Deviation 17.02	9.0 Units on a scale Standard Deviation 23.98
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Mental Summary: Change at Week 12 (n=40,25)	4.5 Units on a scale Standard Deviation 7.85	3.3 Units on a scale Standard Deviation 11.48
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 Physical Summary: Change at Week 12 (n=40,25)	4.4 Units on a scale Standard Deviation 11.22	2.8 Units on a scale Standard Deviation 11.56

Adverse Events

Tapentadol

Serious events: 4 serious events

Other events: 52 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tapentadol n=60 participants at risk Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.	Placebo n=31 participants at risk Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Infections and infestations Urinary tract infection	0.00% 0/60 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.2% 1/31 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Psychiatric disorders Delirium	1.7% 1/60 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/31 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Nervous system disorders Loss of consciousness	0.00% 0/60 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.2% 1/31 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Cardiac disorders Angina pectoris	1.7% 1/60 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/31 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Gastrointestinal disorders Vomiting	1.7% 1/60 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/31 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.00% 0/60 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	3.2% 1/31 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
General disorders Drug withdrawal syndrome	1.7% 1/60 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	0.00% 0/31 • Baseline up to Week 12 An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Other adverse events

Additional Information

Manager

Neuroscience department, clinical science department, R&D in Janssen Japan, Chiyodaku, Tokyo 101-0065 Japan

Phone: +81-3-4411-5509

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER