Trial Outcomes & Findings for An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants (NCT NCT01124604)
NCT ID: NCT01124604
Last Updated: 2013-05-14
Results Overview
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2013-05-14
Participant Flow
Participant milestones
| Measure |
Tapentadol Hydrochloride
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
31
|
|
Overall Study
COMPLETED
|
45
|
29
|
|
Overall Study
NOT COMPLETED
|
15
|
2
|
Reasons for withdrawal
| Measure |
Tapentadol Hydrochloride
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Disease Progression
|
0
|
1
|
Baseline Characteristics
An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants
Baseline characteristics by cohort
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.6 Years
STANDARD_DEVIATION 15.54 • n=5 Participants
|
68.1 Years
STANDARD_DEVIATION 13.73 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 15.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
Baseline
|
6.9 Units on a scale
Standard Deviation 1.17
|
6.9 Units on a scale
Standard Deviation 1.12
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
Change at Week 12
|
-3.0 Units on a scale
Standard Deviation 1.99
|
-2.9 Units on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. LOCF method was used to impute missing values.
Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 1
|
-0.6 Units on a scale
Standard Deviation 1.03
|
-0.7 Units on a scale
Standard Deviation 1.08
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 2
|
-1.1 Units on a scale
Standard Deviation 1.26
|
-1.3 Units on a scale
Standard Deviation 1.55
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 3
|
-1.5 Units on a scale
Standard Deviation 1.54
|
-1.6 Units on a scale
Standard Deviation 1.59
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 4
|
-1.9 Units on a scale
Standard Deviation 1.59
|
-1.8 Units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 5
|
-2.4 Units on a scale
Standard Deviation 1.63
|
-2.0 Units on a scale
Standard Deviation 1.71
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 6
|
-2.7 Units on a scale
Standard Deviation 1.90
|
-2.3 Units on a scale
Standard Deviation 1.82
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 7
|
-2.7 Units on a scale
Standard Deviation 1.86
|
-2.6 Units on a scale
Standard Deviation 2.01
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 8
|
-2.8 Units on a scale
Standard Deviation 1.91
|
-2.6 Units on a scale
Standard Deviation 2.08
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 9
|
-2.9 Units on a scale
Standard Deviation 1.90
|
-2.7 Units on a scale
Standard Deviation 2.12
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 10
|
-2.9 Units on a scale
Standard Deviation 1.98
|
-2.8 Units on a scale
Standard Deviation 2.25
|
|
Change From Baseline in 11-point Numerical Rating Scale (NRS)
Change at Week 11
|
-3.0 Units on a scale
Standard Deviation 2.02
|
-2.9 Units on a scale
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data.
Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 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
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
Greater than or equal to 30 percent improvement
|
55.0 Percentage of participants
95% Confidence Interval 1.17 • Interval 41.61 to 67.88
|
61.3 Percentage of participants
95% Confidence Interval 1.12 • Interval 42.19 to 78.15
|
|
Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
Greater than or equal to 50 percent improvement
|
40.0 Percentage of participants
Interval 27.56 to 53.46
|
48.4 Percentage of participants
Interval 30.15 to 66.94
|
SECONDARY outcome
Timeframe: Week 8, Week 12Population: FAS included all participants who received study drug and had 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.
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
| Measure |
Tapentadol Hydrochloride
n=47 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=29 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 8; Very Much Improved (n = 47, 29)
|
13 Participants
1.17 • Interval 41.61 to 67.88
|
5 Participants
1.12 • Interval 42.19 to 78.15
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 8; Much Improved (n = 47, 29)
|
17 Participants
Interval 27.56 to 53.46
|
9 Participants
Interval 30.15 to 66.94
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 8; Minimally Improved (n = 47, 29)
|
12 Participants
|
9 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 8; No Change (n = 47, 29)
|
2 Participants
|
4 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 8; Minimally Worse (n = 47, 29)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 8; Much Worse (n = 47, 29)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 12; Very Much Improved (n = 45, 29)
|
14 Participants
|
5 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 12; Much Improved (n = 45, 29)
|
16 Participants
|
9 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 12; Minimally Improved (n = 45, 29)
|
9 Participants
|
8 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 12; No Change (n = 45, 29)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 12 ; Minimally Worse (n = 45, 29)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
Week 12; Much Worse (n = 45, 29)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 8, Week 12Population: FAS included all participants who received study drug and had 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.
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 "not effective".
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=47 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=29 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Response Based on Physician's Global Assessment Scale
Week 8; Effective (n=47, 29)
|
41 Participants
|
24 Participants
|
|
Number of Participants With Response Based on Physician's Global Assessment Scale
Week 8; Not effective (n=47, 29)
|
6 Participants
|
5 Participants
|
|
Number of Participants With Response Based on Physician's Global Assessment Scale
Week 12; Effective (n=45, 29)
|
40 Participants
|
21 Participants
|
|
Number of Participants With Response Based on Physician's Global Assessment Scale
Week 12; Not effective (n=45, 29)
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
BPI-sf is a self-evaluated pain assessment form consisting 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). Item 1 for presence of pain assesses the question: "Do you have any pain today other than everyday kinds of pain?" on a 2-point scale of "yes" or "no".
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
Baseline (n=60,31)
|
46 Participants
1.17 • Interval 41.61 to 67.88
|
25 Participants
1.12 • Interval 42.19 to 78.15
|
|
Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
Week 12 (n=45, 29)
|
25 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
BPI-sf is a self-evaluated pain assessment form consisting 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). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
Baseline (n=60, 31)
|
9 Participants
1.17 • Interval 41.61 to 67.88
|
7 Participants
1.12 • Interval 42.19 to 78.15
|
|
Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
Week 12 (n=45, 29)
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
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. Negative change indicates an improvement in pain.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
Total Score; Baseline (n=60, 31)
|
5.4 Units on a scale
Standard Deviation 1.63
|
5.7 Units on a scale
Standard Deviation 1.36
|
|
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
Total Score; Change at Week 12 (n=45, 29)
|
-2.4 Units on a scale
Standard Deviation 2.01
|
-2.3 Units on a scale
Standard Deviation 2.11
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Sleep Latency was addressed by the question: "How long after bedtime/lights out did you fall asleep last night?" and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=45 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=29 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
|
1.0 Minutes
Standard Deviation 41.06
|
1.2 Minutes
Standard Deviation 31.20
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Time slept was addressed by the question: "How long did you sleep last night?" and the change from Baseline in time slept was reported.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=45 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=29 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
|
0.1 Hours
Standard Deviation 1.50
|
0.2 Hours
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
Number of awakenings was addressed by the question: "How many times did you wake up during the night?'' and lesser number signified better sleep.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Week 12; 4 awakenings (n=45,29)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Baseline; 0 awakening (n=60,31)
|
10 Participants
Interval 41.61 to 67.88
|
6 Participants
Interval 42.19 to 78.15
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Baseline; 1 awakening (n=60,31)
|
18 Participants
1.55
|
6 Participants
1.00
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Baseline; 2 awakenings (n=60,31)
|
16 Participants
|
10 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Baseline; 3 awakenings (n=60,31)
|
10 Participants
|
7 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Baseline; 4 awakenings (n=60,31)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Baseline; >= 5 awakenings (n=60,31)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Week 12; 0 awakening (n=45,29)
|
9 Participants
|
6 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Week 12; 1 awakening (n=45,29)
|
20 Participants
|
9 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Week 12; 2 awakenings (n=45,29)
|
9 Participants
|
6 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Week 12; 3 awakenings (n=45,29)
|
3 Participants
|
7 Participants
|
|
Number of Participants With Awakenings Based on Sleep Questionnaire
Week 12; >=5 awakenings (n=45,29)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
Overall quality of sleep was addressed by the question: "Please rate the overall quality of your sleep last night" and participants could choose one of the following options: excellent, good, fair or poor.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Baseline; Excellent (n=60, 31)
|
1 Participants
Interval 41.61 to 67.88
|
1 Participants
Interval 42.19 to 78.15
|
|
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Baseline; Good (n=60, 31)
|
37 Participants
1.55
|
17 Participants
1.00
|
|
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Baseline; Fair (n=60, 31)
|
19 Participants
|
13 Participants
|
|
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Baseline; Poor (n=60, 31)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Week 12; Excellent (n=45, 29)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Week 12; Good (n=45, 29)
|
30 Participants
|
21 Participants
|
|
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Week 12; Fair (n=45, 29)
|
9 Participants
|
7 Participants
|
|
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Week 12; Poor (n=45, 29)
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
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
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Physical Functioning; Baseline (n=60, 31)
|
48.9 Units on a scale
Standard Deviation 18.18 • Interval 41.61 to 67.88
|
51.9 Units on a scale
Standard Deviation 24.65 • Interval 42.19 to 78.15
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Physical Functioning; Change at Week 12 (n=45, 29)
|
12.1 Units on a scale
Standard Deviation 18.01
|
3.4 Units on a scale
Standard Deviation 16.26
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Role-Physical; Baseline (n=60, 31)
|
57.8 Units on a scale
Standard Deviation 27.46
|
57.1 Units on a scale
Standard Deviation 26.41
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Role-Physical; Change at Week 12 (n=45, 29)
|
9.6 Units on a scale
Standard Deviation 30.05
|
-0.4 Units on a scale
Standard Deviation 32.13
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Bodily Pain; Baseline (n=60, 31)
|
34.7 Units on a scale
Standard Deviation 15.53
|
34.3 Units on a scale
Standard Deviation 14.80
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Bodily Pain; Change at Week 12 (n=45, 29)
|
19.4 Units on a scale
Standard Deviation 20.91
|
15.1 Units on a scale
Standard Deviation 19.89
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
General Health; Baseline (n=60, 31)
|
47.6 Units on a scale
Standard Deviation 15.14
|
47.8 Units on a scale
Standard Deviation 18.13
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
General Health; Change at Week 12 (n=45, 29)
|
9.1 Units on a scale
Standard Deviation 13.81
|
4.7 Units on a scale
Standard Deviation 14.18
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Vitality; Baseline (n=60, 31)
|
46.4 Units on a scale
Standard Deviation 21.54
|
51.4 Units on a scale
Standard Deviation 16.67
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Vitality; Change at Week 12 (n=45, 29)
|
7.6 Units on a scale
Standard Deviation 16.20
|
3.7 Units on a scale
Standard Deviation 17.56
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Social Functioning; Baseline (n=60, 31)
|
66.5 Units on a scale
Standard Deviation 26.29
|
66.1 Units on a scale
Standard Deviation 23.09
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Social Functioning; Change at Week 12 (n=45, 29)
|
12.5 Units on a scale
Standard Deviation 21.65
|
5.2 Units on a scale
Standard Deviation 32.13
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Role-Emotional; Baseline (n=60, 31)
|
63.6 Units on a scale
Standard Deviation 28.29
|
61.0 Units on a scale
Standard Deviation 28.25
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Role-Emotional; Change at Week 12 (n=45, 29)
|
10.7 Units on a scale
Standard Deviation 25.23
|
2.6 Units on a scale
Standard Deviation 31.58
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Mental Health; Baseline (n=60, 31)
|
58.7 Units on a scale
Standard Deviation 22.17
|
59.7 Units on a scale
Standard Deviation 20.08
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Mental Health; Change at Week 12 (n=45, 29)
|
7.4 Units on a scale
Standard Deviation 20.16
|
6.4 Units on a scale
Standard Deviation 19.08
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Mental Summary; Baseline (n=60, 31)
|
47.5 Units on a scale
Standard Deviation 10.60
|
48.6 Units on a scale
Standard Deviation 9.99
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Mental Summary; Change at Week 12 (n=45, 29)
|
3.6 Units on a scale
Standard Deviation 7.49
|
3.6 Units on a scale
Standard Deviation 8.71
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Physical Summary; Baseline (n=60, 31)
|
25.5 Units on a scale
Standard Deviation 13.60
|
25.2 Units on a scale
Standard Deviation 16.75
|
|
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Physical Summary; Change at Week 12 (n=45, 29)
|
7.9 Units on a scale
Standard Deviation 12.78
|
1.3 Units on a scale
Standard Deviation 15.76
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had 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.
WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=27 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=13 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
Global Score; Baseline (n=27, 13)
|
1.9 Units on a scale
Standard Deviation 0.64
|
1.7 Units on a scale
Standard Deviation 0.64
|
|
Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
Global Score; Change at Week 12 (n=20, 13)
|
-0.9 Units on a scale
Standard Deviation 0.56
|
-0.4 Units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had 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.
RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as "Yes"/"No" where "Yes" is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=33 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=18 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
Baseline (n=33, 18)
|
11.7 Units on a scale
Standard Deviation 5.08
|
12.7 Units on a scale
Standard Deviation 5.35
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
Change at Week 12 (n=25, 16)
|
-3.3 Units on a scale
Standard Deviation 4.25
|
-1.8 Units on a scale
Standard Deviation 3.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Safety population included all the participants who received at least 1 dose of the study drug.
COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 Participants
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
No Withdrawal
|
60 Participants
1.17 • Interval 41.61 to 67.88
|
31 Participants
1.12 • Interval 42.19 to 78.15
|
|
Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
Moderate
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
Moderately Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
Severe Withdrawal
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2, 4, 8, 12Population: Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 serum study drug concentration. '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.
Outcome measures
| Measure |
Tapentadol Hydrochloride
n=60 Participants
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 200 mg Week 8, n=4
|
87.8 nanogram per milliliter
Standard Deviation 58.9
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 250 mg Week 8, n=4
|
147 nanogram per milliliter
Standard Deviation 119
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 25 mg Week 2, n=11
|
14.1 nanogram per milliliter
Standard Deviation 6.02
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 50 mg Week 2, n=48
|
29.7 nanogram per milliliter
Standard Deviation 17.1
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 100 mg Week 2, n=1
|
47.9 nanogram per milliliter
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable at given time point.
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 150 mg Week 2, n=0
|
NA nanogram per milliliter
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this dose at given time point.
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 200 mg Week 2, n=0
|
NA nanogram per milliliter
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this dose at given time point.
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 250 mg Week 2, n=0
|
NA nanogram per milliliter
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this dose at given time point.
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 25 mg Week 4, n=4
|
22.8 nanogram per milliliter
Standard Deviation 11.6
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 50 mg Week 4, n=10
|
23.6 nanogram per milliliter
Standard Deviation 6.20
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 100 mg Week 4, n=28
|
59.0 nanogram per milliliter
Standard Deviation 42.7
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 150 mg Week 4, n=16
|
76.2 nanogram per milliliter
Standard Deviation 48.5
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 200 mg Week 4, n=0
|
NA nanogram per milliliter
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this dose at given time point.
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 250 mg Week 4, n=0
|
NA nanogram per milliliter
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this dose at given time point.
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 25 mg Week 8, n=3
|
25.1 nanogram per milliliter
Standard Deviation 15.3
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 50 mg Week 8, n=8
|
22.7 nanogram per milliliter
Standard Deviation 12.2
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 100 mg Week 8, n=16
|
57.7 nanogram per milliliter
Standard Deviation 40.7
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 150 mg Week 8, n=13
|
83.2 nanogram per milliliter
Standard Deviation 35.9
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 25 mg Week 12, n=3
|
29.2 nanogram per milliliter
Standard Deviation 13.2
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 50 mg Week 12, n=8
|
25.1 nanogram per milliliter
Standard Deviation 8.17
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 100 mg Week 12, n=14
|
49.1 nanogram per milliliter
Standard Deviation 36.3
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 150 mg Week 12, n=12
|
40.4 nanogram per milliliter
Standard Deviation 33.9
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 200 mg Week 12, n=4
|
119 nanogram per milliliter
Standard Deviation 165
|
—
|
|
Serum Concentration of Tapentadol
Tapentadol Hydrochloride 250 mg Week 12, n=4
|
130 nanogram per milliliter
Standard Deviation 77.6
|
—
|
Adverse Events
Tapentadol Hydrochloride
Serious events: 3 serious events
Other events: 54 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tapentadol Hydrochloride
n=60 participants at risk
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 participants at risk
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Vascular disorders
Aortic dissection
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
Other adverse events
| Measure |
Tapentadol Hydrochloride
n=60 participants at risk
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
Placebo
n=31 participants at risk
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
23.3%
14/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Infections and infestations
Cystitis
|
5.0%
3/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
15.0%
9/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Psychiatric disorders
Insomnia
|
11.7%
7/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Nervous system disorders
Somnolence
|
36.7%
22/60 • Baseline up to 30 days post last study dose
|
9.7%
3/31 • Baseline up to 30 days post last study dose
|
|
Nervous system disorders
Dizziness
|
8.3%
5/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Nervous system disorders
Headache
|
8.3%
5/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Nausea
|
33.3%
20/60 • Baseline up to 30 days post last study dose
|
16.1%
5/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Constipation
|
21.7%
13/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Vomiting
|
18.3%
11/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
6/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
4/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.0%
3/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
4/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Renal and urinary disorders
Renal impairment
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
General disorders
Thirst
|
10.0%
6/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
General disorders
Drug withdrawal syndrome
|
10.0%
6/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
General disorders
Malaise
|
8.3%
5/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Blood creatine phosphokinase increased
|
5.0%
3/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Blood pressure increased
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Blood triglycerides increased
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
6.5%
2/31 • Baseline up to 30 days post last study dose
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
4/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.0%
3/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
General disorders
Asthenia
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
General disorders
Feeling abnormal
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
General disorders
Pyrexia
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
General disorders
Face oedema
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
General disorders
Feeling cold
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Infections and infestations
Pharyngitis
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Infections and infestations
Bronchitis
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Infections and infestations
Oral herpes
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Blood urea increased
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Blood urine present
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Investigations
White blood cell count increased
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Blood creatinine increased
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Eosinophil count increased
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Glucose urine present
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Neutrophil count increased
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Respiratory rate increased
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Electrocardiogram T wave abnormal
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Platelet count increased
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Protein urine present
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Investigations
Blood alkaline phosphatase increased
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Nervous system disorders
Hypoaesthesia
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Nervous system disorders
Sciatica
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Nervous system disorders
Tremor
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Psychiatric disorders
Abnormal dreams
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Psychiatric disorders
Hallucination
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Renal and urinary disorders
Oliguria
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Renal and urinary disorders
Renal disorder
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Immune system disorders
Contrast media allergy
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Eye disorders
Visual impairment
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Ear and labyrinth disorders
Vertigo
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Cardiac disorders
Palpitations
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Vascular disorders
Hypertension
|
3.3%
2/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Vascular disorders
Vascular insufficiency
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/60 • Baseline up to 30 days post last study dose
|
3.2%
1/31 • Baseline up to 30 days post last study dose
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.7%
1/60 • Baseline up to 30 days post last study dose
|
0.00%
0/31 • Baseline up to 30 days post last study dose
|
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 The disclosure restriction on PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
- Publication restrictions are in place
Restriction type: OTHER