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Trial record 29 of 34 for:    "Osteoarthritis" | ( Map: Japan )

An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01124604
Recruitment Status : Completed
First Posted : May 17, 2010
Results First Posted : April 17, 2013
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Pain
Low Back Pain
Back Pain
Osteoarthritis, Knee
Interventions Drug: Tapentadol Hydrochloride
Drug: Placebo
Enrollment 91
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 60 31
Completed 45 29
Not Completed 15 2
Reason Not Completed
Adverse Event             10             1
Lack of Efficacy             1             0
Withdrawal by Subject             4             0
Disease Progression             0             1
Arm/Group Title Tapentadol Hydrochloride Placebo Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 60 31 91
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 31 participants 91 participants
63.6  (15.54) 68.1  (13.73) 65.1  (15.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 31 participants 91 participants
Female
42
  70.0%
20
  64.5%
62
  68.1%
Male
18
  30.0%
11
  35.5%
29
  31.9%
1.Primary Outcome
Title Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 6.9  (1.17) 6.9  (1.12)
Change at Week 12 -3.0  (1.99) -2.9  (2.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol Hydrochloride, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Square (LS) Mean Difference
Estimated Value -0.1
Confidence Interval 95%
-1.04 to 0.80
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.46
Estimation Comments Test for no difference between treatments was derived from Analysis of covariance (ANCOVA) model with factors treatment, disease and Baseline pain intensity as covariate.
2.Secondary Outcome
Title Change From Baseline in 11-point Numerical Rating Scale (NRS)
Hide Description 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.
Time Frame Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 1 -0.6  (1.03) -0.7  (1.08)
Change at Week 2 -1.1  (1.26) -1.3  (1.55)
Change at Week 3 -1.5  (1.54) -1.6  (1.59)
Change at Week 4 -1.9  (1.59) -1.8  (1.71)
Change at Week 5 -2.4  (1.63) -2.0  (1.71)
Change at Week 6 -2.7  (1.90) -2.3  (1.82)
Change at Week 7 -2.7  (1.86) -2.6  (2.01)
Change at Week 8 -2.8  (1.91) -2.6  (2.08)
Change at Week 9 -2.9  (1.90) -2.7  (2.12)
Change at Week 10 -2.9  (1.98) -2.8  (2.25)
Change at Week 11 -3.0  (2.02) -2.9  (2.25)
3.Secondary Outcome
Title Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Greater than or equal to 30 percent improvement
55.0
(41.61 to 67.88)
61.3
(42.19 to 78.15)
Greater than or equal to 50 percent improvement
40.0
(27.56 to 53.46)
48.4
(30.15 to 66.94)
4.Secondary Outcome
Title Number of Participants With Categorical Scores on Patient’s Global Impression of Change (PGIC) Scale
Hide Description 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.
Time Frame Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 47 29
Measure Type: Number
Unit of Measure: Participants
Week 8; Very Much Improved (n = 47, 29) 13 5
Week 8; Much Improved (n = 47, 29) 17 9
Week 8; Minimally Improved (n = 47, 29) 12 9
Week 8; No Change (n = 47, 29) 2 4
Week 8; Minimally Worse (n = 47, 29) 1 2
Week 8; Much Worse (n = 47, 29) 2 0
Week 12; Very Much Improved (n = 45, 29) 14 5
Week 12; Much Improved (n = 45, 29) 16 9
Week 12; Minimally Improved (n = 45, 29) 9 8
Week 12; No Change (n = 45, 29) 4 5
Week 12 ; Minimally Worse (n = 45, 29) 0 2
Week 12; Much Worse (n = 45, 29) 2 0
5.Secondary Outcome
Title Number of Participants With Response Based on Physician’s Global Assessment Scale
Hide Description 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".
Time Frame Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 47 29
Measure Type: Number
Unit of Measure: Participants
Week 8; Effective (n=47, 29) 41 24
Week 8; Not effective (n=47, 29) 6 5
Week 12; Effective (n=45, 29) 40 21
Week 12; Not effective (n=45, 29) 5 8
6.Secondary Outcome
Title Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
Hide Description 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”.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Measure Type: Number
Unit of Measure: Participants
Baseline (n=60,31) 46 25
Week 12 (n=45, 29) 25 21
7.Secondary Outcome
Title Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
Hide Description 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).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Measure Type: Number
Unit of Measure: Participants
Baseline (n=60, 31) 9 7
Week 12 (n=45, 29) 10 4
8.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Total Score; Baseline (n=60, 31) 5.4  (1.63) 5.7  (1.36)
Total Score; Change at Week 12 (n=45, 29) -2.4  (2.01) -2.3  (2.11)
9.Secondary Outcome
Title Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 45 29
Mean (Standard Deviation)
Unit of Measure: Minutes
1.0  (41.06) 1.2  (31.20)
10.Secondary Outcome
Title Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
Hide Description Time slept was addressed by the question: "How long did you sleep last night?" and the change from Baseline in time slept was reported.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 45 29
Mean (Standard Deviation)
Unit of Measure: Hours
0.1  (1.50) 0.2  (1.04)
11.Secondary Outcome
Title Number of Participants With Awakenings Based on Sleep Questionnaire
Hide Description Number of awakenings was addressed by the question: "How many times did you wake up during the night?'' and lesser number signified better sleep.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Measure Type: Number
Unit of Measure: Participants
Baseline; 0 awakening (n=60,31) 10 6
Baseline; 1 awakening (n=60,31) 18 6
Baseline; 2 awakenings (n=60,31) 16 10
Baseline; 3 awakenings (n=60,31) 10 7
Baseline; 4 awakenings (n=60,31) 2 1
Baseline; >= 5 awakenings (n=60,31) 4 1
Week 12; 0 awakening (n=45,29) 9 6
Week 12; 1 awakening (n=45,29) 20 9
Week 12; 2 awakenings (n=45,29) 9 6
Week 12; 3 awakenings (n=45,29) 3 7
Week 12; 4 awakenings (n=45,29) 2 1
Week 12; >=5 awakenings (n=45,29) 2 0
12.Secondary Outcome
Title Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Measure Type: Number
Unit of Measure: Participants
Baseline; Excellent (n=60, 31) 1 1
Baseline; Good (n=60, 31) 37 17
Baseline; Fair (n=60, 31) 19 13
Baseline; Poor (n=60, 31) 3 0
Week 12; Excellent (n=45, 29) 2 0
Week 12; Good (n=45, 29) 30 21
Week 12; Fair (n=45, 29) 9 7
Week 12; Poor (n=45, 29) 4 1
13.Secondary Outcome
Title Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Physical Functioning; Baseline (n=60, 31) 48.9  (18.18) 51.9  (24.65)
Physical Functioning; Change at Week 12 (n=45, 29) 12.1  (18.01) 3.4  (16.26)
Role-Physical; Baseline (n=60, 31) 57.8  (27.46) 57.1  (26.41)
Role-Physical; Change at Week 12 (n=45, 29) 9.6  (30.05) -0.4  (32.13)
Bodily Pain; Baseline (n=60, 31) 34.7  (15.53) 34.3  (14.80)
Bodily Pain; Change at Week 12 (n=45, 29) 19.4  (20.91) 15.1  (19.89)
General Health; Baseline (n=60, 31) 47.6  (15.14) 47.8  (18.13)
General Health; Change at Week 12 (n=45, 29) 9.1  (13.81) 4.7  (14.18)
Vitality; Baseline (n=60, 31) 46.4  (21.54) 51.4  (16.67)
Vitality; Change at Week 12 (n=45, 29) 7.6  (16.20) 3.7  (17.56)
Social Functioning; Baseline (n=60, 31) 66.5  (26.29) 66.1  (23.09)
Social Functioning; Change at Week 12 (n=45, 29) 12.5  (21.65) 5.2  (32.13)
Role-Emotional; Baseline (n=60, 31) 63.6  (28.29) 61.0  (28.25)
Role-Emotional; Change at Week 12 (n=45, 29) 10.7  (25.23) 2.6  (31.58)
Mental Health; Baseline (n=60, 31) 58.7  (22.17) 59.7  (20.08)
Mental Health; Change at Week 12 (n=45, 29) 7.4  (20.16) 6.4  (19.08)
Mental Summary; Baseline (n=60, 31) 47.5  (10.60) 48.6  (9.99)
Mental Summary; Change at Week 12 (n=45, 29) 3.6  (7.49) 3.6  (8.71)
Physical Summary; Baseline (n=60, 31) 25.5  (13.60) 25.2  (16.75)
Physical Summary; Change at Week 12 (n=45, 29) 7.9  (12.78) 1.3  (15.76)
14.Secondary Outcome
Title Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 27 13
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Global Score; Baseline (n=27, 13) 1.9  (0.64) 1.7  (0.64)
Global Score; Change at Week 12 (n=20, 13) -0.9  (0.56) -0.4  (0.66)
15.Secondary Outcome
Title Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 33 18
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n=33, 18) 11.7  (5.08) 12.7  (5.35)
Change at Week 12 (n=25, 16) -3.3  (4.25) -1.8  (3.04)
16.Other Pre-specified Outcome
Title Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the participants who received at least 1 dose of the study drug.
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 60 31
Measure Type: Number
Unit of Measure: Participants
No Withdrawal 60 31
Mild 0 0
Moderate 0 0
Moderately Severe 0 0
Severe Withdrawal 0 0
17.Other Pre-specified Outcome
Title Serum Concentration of Tapentadol
Hide Description [Not Specified]
Time Frame Week 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tapentadol Hydrochloride
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 60
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
Tapentadol Hydrochloride 25 mg Week 2, n=11 14.1  (6.02)
Tapentadol Hydrochloride 50 mg Week 2, n=48 29.7  (17.1)
Tapentadol Hydrochloride 100 mg Week 2, n=1 47.9 [1]   (NA)
Tapentadol Hydrochloride 150 mg Week 2, n=0 NA [2]   (NA)
Tapentadol Hydrochloride 200 mg Week 2, n=0 NA [2]   (NA)
Tapentadol Hydrochloride 250 mg Week 2, n=0 NA [2]   (NA)
Tapentadol Hydrochloride 25 mg Week 4, n=4 22.8  (11.6)
Tapentadol Hydrochloride 50 mg Week 4, n=10 23.6  (6.20)
Tapentadol Hydrochloride 100 mg Week 4, n=28 59.0  (42.7)
Tapentadol Hydrochloride 150 mg Week 4, n=16 76.2  (48.5)
Tapentadol Hydrochloride 200 mg Week 4, n=0 NA [2]   (NA)
Tapentadol Hydrochloride 250 mg Week 4, n=0 NA [2]   (NA)
Tapentadol Hydrochloride 25 mg Week 8, n=3 25.1  (15.3)
Tapentadol Hydrochloride 50 mg Week 8, n=8 22.7  (12.2)
Tapentadol Hydrochloride 100 mg Week 8, n=16 57.7  (40.7)
Tapentadol Hydrochloride 150 mg Week 8, n=13 83.2  (35.9)
Tapentadol Hydrochloride 200 mg Week 8, n=4 87.8  (58.9)
Tapentadol Hydrochloride 250 mg Week 8, n=4 147  (119)
Tapentadol Hydrochloride 25 mg Week 12, n=3 29.2  (13.2)
Tapentadol Hydrochloride 50 mg Week 12, n=8 25.1  (8.17)
Tapentadol Hydrochloride 100 mg Week 12, n=14 49.1  (36.3)
Tapentadol Hydrochloride 150 mg Week 12, n=12 40.4  (33.9)
Tapentadol Hydrochloride 200 mg Week 12, n=4 119  (165)
Tapentadol Hydrochloride 250 mg Week 12, n=4 130  (77.6)
[1]
Standard deviation was not estimable as only 1 participant was evaluable at given time point.
[2]
Data was not analyzed as no participant was evaluable for this dose at given time point.
Time Frame Baseline up to 30 days post last study dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapentadol Hydrochloride Placebo
Hide Arm/Group Description 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 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.
All-Cause Mortality
Tapentadol Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tapentadol Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/60 (5.00%)   0/31 (0.00%) 
Gastrointestinal disorders     
Vomiting * 1  1/60 (1.67%)  0/31 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal * 1  1/60 (1.67%)  0/31 (0.00%) 
Vascular disorders     
Aortic dissection * 1  1/60 (1.67%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tapentadol Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   54/60 (90.00%)   24/31 (77.42%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/60 (0.00%)  1/31 (3.23%) 
Cardiac disorders     
Palpitations * 1  1/60 (1.67%)  0/31 (0.00%) 
Ear and labyrinth disorders     
Vertigo * 1  1/60 (1.67%)  0/31 (0.00%) 
Eye disorders     
Visual impairment * 1  1/60 (1.67%)  0/31 (0.00%) 
Gastrointestinal disorders     
Nausea * 1  20/60 (33.33%)  5/31 (16.13%) 
Constipation * 1  13/60 (21.67%)  2/31 (6.45%) 
Vomiting * 1  11/60 (18.33%)  1/31 (3.23%) 
Diarrhoea * 1  6/60 (10.00%)  2/31 (6.45%) 
Abdominal discomfort * 1  0/60 (0.00%)  2/31 (6.45%) 
Dyspepsia * 1  1/60 (1.67%)  1/31 (3.23%) 
Colonic polyp * 1  0/60 (0.00%)  1/31 (3.23%) 
Dry mouth * 1  1/60 (1.67%)  0/31 (0.00%) 
Gastric ulcer * 1  0/60 (0.00%)  1/31 (3.23%) 
Haemorrhoids * 1  1/60 (1.67%)  0/31 (0.00%) 
Toothache * 1  1/60 (1.67%)  0/31 (0.00%) 
General disorders     
Thirst * 1  6/60 (10.00%)  2/31 (6.45%) 
Drug withdrawal syndrome * 1  6/60 (10.00%)  0/31 (0.00%) 
Malaise * 1  5/60 (8.33%)  1/31 (3.23%) 
Asthenia * 1  1/60 (1.67%)  1/31 (3.23%) 
Feeling abnormal * 1  2/60 (3.33%)  0/31 (0.00%) 
Pyrexia * 1  2/60 (3.33%)  0/31 (0.00%) 
Face oedema * 1  1/60 (1.67%)  0/31 (0.00%) 
Feeling cold * 1  1/60 (1.67%)  0/31 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal * 1  0/60 (0.00%)  1/31 (3.23%) 
Liver disorder * 1  0/60 (0.00%)  1/31 (3.23%) 
Immune system disorders     
Contrast media allergy * 1  1/60 (1.67%)  0/31 (0.00%) 
Infections and infestations     
Nasopharyngitis * 1  14/60 (23.33%)  2/31 (6.45%) 
Cystitis * 1  3/60 (5.00%)  0/31 (0.00%) 
Pharyngitis * 1  2/60 (3.33%)  1/31 (3.23%) 
Bronchitis * 1  0/60 (0.00%)  1/31 (3.23%) 
Herpes zoster * 1  0/60 (0.00%)  1/31 (3.23%) 
Oral herpes * 1  1/60 (1.67%)  0/31 (0.00%) 
Injury, poisoning and procedural complications     
Contusion * 1  4/60 (6.67%)  0/31 (0.00%) 
Thermal burn * 1  3/60 (5.00%)  0/31 (0.00%) 
Radius fracture * 1  0/60 (0.00%)  1/31 (3.23%) 
Investigations     
Blood creatine phosphokinase increased * 1  3/60 (5.00%)  2/31 (6.45%) 
Blood pressure increased * 1  1/60 (1.67%)  2/31 (6.45%) 
Blood triglycerides increased * 1  1/60 (1.67%)  2/31 (6.45%) 
Blood urea increased * 1  2/60 (3.33%)  1/31 (3.23%) 
Blood lactate dehydrogenase increased * 1  2/60 (3.33%)  0/31 (0.00%) 
Blood urine present * 1  1/60 (1.67%)  1/31 (3.23%) 
White blood cell count increased * 1  2/60 (3.33%)  0/31 (0.00%) 
Blood creatinine increased * 1  1/60 (1.67%)  0/31 (0.00%) 
Electrocardiogram T wave inversion * 1  0/60 (0.00%)  1/31 (3.23%) 
Eosinophil count increased * 1  1/60 (1.67%)  0/31 (0.00%) 
Glucose urine present * 1  0/60 (0.00%)  1/31 (3.23%) 
Neutrophil count increased * 1  1/60 (1.67%)  0/31 (0.00%) 
Respiratory rate increased * 1  0/60 (0.00%)  1/31 (3.23%) 
Electrocardiogram T wave abnormal * 1  1/60 (1.67%)  0/31 (0.00%) 
Platelet count increased * 1  1/60 (1.67%)  0/31 (0.00%) 
Protein urine present * 1  1/60 (1.67%)  0/31 (0.00%) 
Blood alkaline phosphatase increased * 1  1/60 (1.67%)  0/31 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  9/60 (15.00%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  4/60 (6.67%)  1/31 (3.23%) 
Back pain * 1  0/60 (0.00%)  1/31 (3.23%) 
Bursitis * 1  0/60 (0.00%)  1/31 (3.23%) 
Muscle spasms * 1  0/60 (0.00%)  1/31 (3.23%) 
Muscular weakness * 1  1/60 (1.67%)  0/31 (0.00%) 
Osteoarthritis * 1  1/60 (1.67%)  0/31 (0.00%) 
Periarthritis * 1  1/60 (1.67%)  0/31 (0.00%) 
Spinal osteoarthritis * 1  1/60 (1.67%)  0/31 (0.00%) 
Tenosynovitis * 1  1/60 (1.67%)  0/31 (0.00%) 
Musculoskeletal stiffness * 1  1/60 (1.67%)  0/31 (0.00%) 
Foot deformity * 1  1/60 (1.67%)  0/31 (0.00%) 
Nervous system disorders     
Somnolence * 1  22/60 (36.67%)  3/31 (9.68%) 
Dizziness * 1  5/60 (8.33%)  2/31 (6.45%) 
Headache * 1  5/60 (8.33%)  1/31 (3.23%) 
Hypoaesthesia * 1  2/60 (3.33%)  0/31 (0.00%) 
Sciatica * 1  1/60 (1.67%)  0/31 (0.00%) 
Tremor * 1  1/60 (1.67%)  0/31 (0.00%) 
Psychiatric disorders     
Insomnia * 1  7/60 (11.67%)  0/31 (0.00%) 
Abnormal dreams * 1  1/60 (1.67%)  0/31 (0.00%) 
Anxiety * 1  1/60 (1.67%)  0/31 (0.00%) 
Hallucination * 1  1/60 (1.67%)  0/31 (0.00%) 
Renal and urinary disorders     
Renal impairment * 1  2/60 (3.33%)  2/31 (6.45%) 
Oliguria * 1  1/60 (1.67%)  0/31 (0.00%) 
Renal disorder * 1  1/60 (1.67%)  0/31 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/60 (1.67%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchitis chronic * 1  1/60 (1.67%)  0/31 (0.00%) 
Yawning * 1  1/60 (1.67%)  0/31 (0.00%) 
Oropharyngeal discomfort * 1  1/60 (1.67%)  0/31 (0.00%) 
Oropharyngeal pain * 1  1/60 (1.67%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  4/60 (6.67%)  1/31 (3.23%) 
Dermatitis contact * 1  3/60 (5.00%)  1/31 (3.23%) 
Rash * 1  1/60 (1.67%)  2/31 (6.45%) 
Hyperhidrosis * 1  2/60 (3.33%)  0/31 (0.00%) 
Urticaria * 1  2/60 (3.33%)  0/31 (0.00%) 
Cold sweat * 1  1/60 (1.67%)  0/31 (0.00%) 
Eczema * 1  0/60 (0.00%)  1/31 (3.23%) 
Erythema * 1  0/60 (0.00%)  1/31 (3.23%) 
Heat rash * 1  1/60 (1.67%)  0/31 (0.00%) 
Vascular disorders     
Hypertension * 1  2/60 (3.33%)  0/31 (0.00%) 
Vascular insufficiency * 1  1/60 (1.67%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Manager
Organization: Neuroscience Department, Clinical Science Department, R&D in Janssen Japan Chiyodaku, Tokyo 101-0065 Japan
Phone: +81-3-4411-5509
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01124604     History of Changes
Other Study ID Numbers: CR016999
JNS024ER-JPN-N21 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: April 22, 2010
First Posted: May 17, 2010
Results First Submitted: March 6, 2013
Results First Posted: April 17, 2013
Last Update Posted: May 14, 2013