Diabetic Neuropathies, Neuralgia, Pain, Postherpetic Neuralgia
Conditions
Keywords
Chronic pain, Diabetic Neuropathic Pain, Neuralgia, Postherpetic, Tapentadol hydrochloride extended-release, JNS024ER, Placebo
Brief summary
The purpose of this study is to investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting after condition has healed).
Detailed description
This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), and parallel-group (each group of participant will be treated at the same time) comparison study in Japanese participants with chronic pain due to painful diabetic peripheral neuropathy or postherpetic neuralgia. The duration of study will be 14 weeks. The study consists of 3 parts: Screening (1 Week before study commences on Day 1); Treatment (12 weeks and will include titration period \[from the initiation of the study treatment to determination of the individual's maintenance dose\] and maintenance period \[from completion of the titration period up to12 week\]); and Follow-up (1 Week). Tapentadol hydrochloride ER oral tablet or matching placebo will be administered twice daily for 12 weeks. Efficacy of the participants will primarily be evaluated through Numerical Rating Scale (NRS). Participants' safety will be monitored throughout the study.
Interventions
DRUGTapentadol
Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
DRUGPlacebo
Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with chronic pain due to painful diabetic neuropathy or postherpetic neuralgia continuing for at least 12 weeks before consent * Participants with adjuvant analgesics (antidepressants, antiepileptics and diabetic peripheral neuropathy drugs) or non-opioid treatment and dissatisfied with current treatment (in sense of efficacy and/or safety) for at least consecutive 14 days during the 12 weeks before consent * Participants have not experienced treatment with conventional opioids, except for the following cases: Short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent; and temporal use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (for example, for antitussive) more than 2 days before consent * Mean pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale during 48 hours before consent and the Investigator or Sub-investigator considers that the participant should be treated with an opioid analgesic * HbA1c within 4 weeks before consent less than or equal to 11percent (in participants with diabetic neuropathic pain)
Exclusion criteria
* Participants have been treated or treated with a monoamine oxidase inhibitor within 14 days before consent * Current or a history of epilepsy or convulsive disorders or hypersensitivity to opioid analgesics * Suggested of intracranial hypertension (for example, traumatic encephalopathy) * Participants who have complicated condition with uncontrolled or clinically significant arrhythmia, or neuropsychiatric disorders * Participants with moderately to severely impaired hepatic function, or severely impaired renal function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Baseline and Week 12 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Week 12 | Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. |
| Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8 and Week 12 | 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. |
| Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 8 and Week 12 | Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and ineffective. |
| Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
| Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent \[no pain\]) to 10 (extreme \[pain as bad as you can image\]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline. |
| Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Baseline and Week 12 | Sleep Latency was related to How long after bedtime or lights out did the participant fall asleep last night . Decrease in time indicates an improvement. |
| Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Baseline and Week 12 | Time slept was related to How long did the participant sleep last night. The mean change for the time in hours slept during the last night was reported. |
| Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline and Week 12 | Number of awakenings was related to How many times did the participant wake up during the night. Lesser number signifies better sleep. |
| Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline and Week 12 | Participants rated the overall quality of sleep last night as excellent, good, fair and poor. |
| Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Baseline and Week 12 | The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. |
| Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | Baseline and Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tapentadol Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. | 60 |
| Placebo Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks. | 31 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | Lack of Efficacy | 2 | 1 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 1 |
Baseline characteristics
| Characteristic | Tapentadol | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 64.6 Years STANDARD_DEVIATION 12.98 | 68.6 Years STANDARD_DEVIATION 11.6 | 65.9 Years STANDARD_DEVIATION 12.61 |
| Sex: Female, Male Female | 26 Participants | 14 Participants | 40 Participants |
| Sex: Female, Male Male | 34 Participants | 17 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 52 / 60 | 26 / 31 |
| serious Total, serious adverse events | 4 / 60 | 3 / 31 |
Outcome results
Primary
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12
Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline.
Time frame: Baseline and Week 12
Population: Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Baseline | 6.7 Units on a scale | Standard Deviation 1.15 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Change at Week 12 | -2.6 Units on a scale | Standard Deviation 2.23 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Baseline | 6.9 Units on a scale | Standard Deviation 1.35 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Change at Week 12 | -2.6 Units on a scale | Standard Deviation 2.65 |
Secondary
Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11
Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11
Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 4 | -1.8 Units on a scale | Standard Deviation 1.88 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 7 | -2.3 Units on a scale | Standard Deviation 2.1 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 3 | -1.5 Units on a scale | Standard Deviation 1.75 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 8 | -2.4 Units on a scale | Standard Deviation 2.12 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 5 | -2.1 Units on a scale | Standard Deviation 1.87 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 9 | -2.5 Units on a scale | Standard Deviation 2.2 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 2 | -1.1 Units on a scale | Standard Deviation 1.47 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 10 | -2.6 Units on a scale | Standard Deviation 2.22 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 6 | -2.3 Units on a scale | Standard Deviation 1.97 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 11 | -2.6 Units on a scale | Standard Deviation 2.25 |
| Tapentadol | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 1 | -0.7 Units on a scale | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 11 | -2.4 Units on a scale | Standard Deviation 2.66 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 1 | -0.2 Units on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 2 | -0.9 Units on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 3 | -1.1 Units on a scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 4 | -1.6 Units on a scale | Standard Deviation 1.78 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 5 | -1.7 Units on a scale | Standard Deviation 2.09 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 6 | -2.0 Units on a scale | Standard Deviation 2.41 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 7 | -2.2 Units on a scale | Standard Deviation 2.55 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 8 | -2.4 Units on a scale | Standard Deviation 2.5 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 9 | -2.4 Units on a scale | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Change at Week 10 | -2.6 Units on a scale | Standard Deviation 2.51 |
Secondary
Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12
The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.
Time frame: Baseline and Week 12
Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | Baseline (n=60,31) | 5.2 Units on a scale | Standard Deviation 1.58 |
| Tapentadol | Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | Change at Week 12 (n=40,25) | -2.7 Units on a scale | Standard Deviation 1.64 |
| Placebo | Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | Baseline (n=60,31) | 5.2 Units on a scale | Standard Deviation 1.52 |
| Placebo | Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | Change at Week 12 (n=40,25) | -2.3 Units on a scale | Standard Deviation 2.29 |
Secondary
Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.
Time frame: Baseline and Week 12
Population: FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline (n=60, 31) | 4.7 Units on a scale | Standard Deviation 2.13 |
| Tapentadol | Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Week 12 (n=25,40) | -2.6 Units on a scale | Standard Deviation 1.92 |
| Placebo | Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline (n=60, 31) | 4.6 Units on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Week 12 (n=25,40) | -2.1 Units on a scale | Standard Deviation 2.48 |
Secondary
Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale
The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent \[no pain\]) to 10 (extreme \[pain as bad as you can image\]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain.
Time frame: Baseline and Week 12
Population: FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline (n=60, 31) | 6.2 Units on a scale | Standard Deviation 1.19 |
| Tapentadol | Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Week 12 (n=25,40) | -3.0 Units on a scale | Standard Deviation 1.72 |
| Placebo | Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Baseline (n=60, 31) | 6.3 Units on a scale | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | Week 12 (n=25,40) | -2.6 Units on a scale | Standard Deviation 2.35 |
Secondary
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
Time frame: Baseline and Week 12
Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Functioning: Baseline (n=60,31) | 68.6 Units on a scale | Standard Deviation 21.88 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Physical: Baseline (n=60,31) | 70.1 Units on a scale | Standard Deviation 27.95 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Bodily Pain: Baseline (n=60,31) | 36.2 Units on a scale | Standard Deviation 16.74 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | General Health: Baseline (n=60,31) | 45.7 Units on a scale | Standard Deviation 16.73 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Vitality: Baseline (n=60,31) | 48.8 Units on a scale | Standard Deviation 23.49 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Social Functioning: Baseline (n=60,31) | 72.9 Units on a scale | Standard Deviation 26.66 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Emotional: Baseline (n=60,31) | 68.9 Units on a scale | Standard Deviation 30.91 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Health: Baseline (n=60,31) | 57.6 Units on a scale | Standard Deviation 24.54 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Summary: Baseline (n=60,31) | 43.9 Units on a scale | Standard Deviation 12.27 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Summary: Baseline (n=60,31) | 36.0 Units on a scale | Standard Deviation 16.11 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Functioning: Change at Week 12 (n=40,25) | 5.4 Units on a scale | Standard Deviation 13.65 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Physical: Change at Week 12 (n=40,25) | 6.6 Units on a scale | Standard Deviation 21.74 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Bodily Pain: Change at Week 12 (n=40,25) | 10.5 Units on a scale | Standard Deviation 15.43 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | General Health: Change at Week 12 (n=40,25) | -0.4 Units on a scale | Standard Deviation 10.74 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Vitality: Change at Week 12 (n=40,25) | 9.4 Units on a scale | Standard Deviation 19.09 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Social Functioning: Change at Week 12 (n=40,25) | 8.1 Units on a scale | Standard Deviation 21.47 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Emotional: Change at Week 12 (n=40,25) | 6.0 Units on a scale | Standard Deviation 27.02 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Health: Change at Week 12 (n=40,25) | 7.8 Units on a scale | Standard Deviation 17.02 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Summary: Change at Week 12 (n=40,25) | 4.5 Units on a scale | Standard Deviation 7.85 |
| Tapentadol | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Summary: Change at Week 12 (n=40,25) | 4.4 Units on a scale | Standard Deviation 11.22 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Health: Change at Week 12 (n=40,25) | 9.0 Units on a scale | Standard Deviation 23.98 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Functioning: Baseline (n=60,31) | 61.0 Units on a scale | Standard Deviation 24.2 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Functioning: Change at Week 12 (n=40,25) | 4.8 Units on a scale | Standard Deviation 14.89 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Physical: Baseline (n=60,31) | 64.3 Units on a scale | Standard Deviation 28.15 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Social Functioning: Change at Week 12 (n=40,25) | 2.0 Units on a scale | Standard Deviation 37.27 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Bodily Pain: Baseline (n=60,31) | 38.8 Units on a scale | Standard Deviation 14.5 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Physical: Change at Week 12 (n=40,25) | 4.8 Units on a scale | Standard Deviation 22.26 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | General Health: Baseline (n=60,31) | 44.7 Units on a scale | Standard Deviation 17.51 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Summary: Change at Week 12 (n=40,25) | 2.8 Units on a scale | Standard Deviation 11.56 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Vitality: Baseline (n=60,31) | 50.4 Units on a scale | Standard Deviation 22.47 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Bodily Pain: Change at Week 12 (n=40,25) | 7.0 Units on a scale | Standard Deviation 15.57 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Social Functioning: Baseline (n=60,31) | 80.2 Units on a scale | Standard Deviation 27.72 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Emotional: Change at Week 12 (n=40,25) | 5.7 Units on a scale | Standard Deviation 25.65 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Emotional: Baseline (n=60,31) | 68.5 Units on a scale | Standard Deviation 28.19 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | General Health: Change at Week 12 (n=40,25) | 0.2 Units on a scale | Standard Deviation 11.83 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Health: Baseline (n=60,31) | 61.8 Units on a scale | Standard Deviation 22.04 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Summary: Change at Week 12 (n=40,25) | 3.3 Units on a scale | Standard Deviation 11.48 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Summary: Baseline (n=60,31) | 47.6 Units on a scale | Standard Deviation 10.65 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Vitality: Change at Week 12 (n=40,25) | 6.8 Units on a scale | Standard Deviation 22.31 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Summary: Baseline (n=60,31) | 31.7 Units on a scale | Standard Deviation 16.48 |
Secondary
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
Sleep Latency was related to How long after bedtime or lights out did the participant fall asleep last night . Decrease in time indicates an improvement.
Time frame: Baseline and Week 12
Population: FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Baseline (n=60, 30) | 45.4 Minutes | Standard Deviation 65.78 |
| Tapentadol | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Change at Week 12 (n=40, 24) | -11.1 Minutes | Standard Deviation 49.15 |
| Placebo | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Baseline (n=60, 30) | 34.7 Minutes | Standard Deviation 28.62 |
| Placebo | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Change at Week 12 (n=40, 24) | -3.1 Minutes | Standard Deviation 30.17 |
Secondary
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
Time slept was related to How long did the participant sleep last night. The mean change for the time in hours slept during the last night was reported.
Time frame: Baseline and Week 12
Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Baseline (n=60, 31) | 5.8 Hours | Standard Deviation 1.29 |
| Tapentadol | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Change at Week 12 (n=40,25) | 0.3 Hours | Standard Deviation 1.71 |
| Placebo | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Baseline (n=60, 31) | 6.4 Hours | Standard Deviation 1.97 |
| Placebo | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Change at Week 12 (n=40,25) | 0.3 Hours | Standard Deviation 1.58 |
Secondary
Number of Participants With Awakenings Based on Sleep Questionnaire
Number of awakenings was related to How many times did the participant wake up during the night. Lesser number signifies better sleep.
Time frame: Baseline and Week 12
Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 0 awakening (n=60,30) | 17 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 1 awakening (n=60,30) | 16 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 2 awakenings (n=60,30) | 10 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 3 awakenings (n=60,30) | 8 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 4 awakenings (n=60,30) | 5 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: > or = 5 awakenings (n=60,30) | 4 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 0 awakening (n=40,25) | 12 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 1 awakening (n=40,25) | 14 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 2 awakenings (n=40,25) | 9 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 3 awakenings (n=40,25) | 1 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 4 awakenings (n=40,25) | 3 Participants |
| Tapentadol | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : > or = 5 awakenings (n=40,25) | 1 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 4 awakenings (n=40,25) | 2 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 0 awakening (n=60,30) | 3 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 0 awakening (n=40,25) | 3 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 1 awakening (n=60,30) | 9 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 3 awakenings (n=40,25) | 4 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 2 awakenings (n=60,30) | 10 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 1 awakening (n=40,25) | 8 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 3 awakenings (n=60,30) | 6 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : > or = 5 awakenings (n=40,25) | 1 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: 4 awakenings (n=60,30) | 1 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12 : 2 awakenings (n=40,25) | 7 Participants |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline: > or = 5 awakenings (n=60,30) | 1 Participants |
Secondary
Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale
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 and Week 12
Population: FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Very Much Improved (n = 46, 26) | 7 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Much Improved (n = 46, 26) | 16 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Minimally Improved (n = 46, 26) | 16 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: No Change (n = 46, 26) | 6 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Minimally Worse (n = 46, 26) | 1 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Much Worse (n = 46, 26) | 1 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Very Much Worse (n = 46, 26) | 0 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12: Very Much Improved (n = 40, 25) | 6 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Much Improved (n = 40, 25) | 18 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Minimally Improved (n = 40, 25) | 13 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : No Change (n = 40, 25) | 2 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Minimally Worse (n = 40, 25) | 0 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Much Worse (n = 40, 25) | 1 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Very Much Worse (n = 40, 25) | 0 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : No Change (n = 40, 25) | 2 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Very Much Improved (n = 46, 26) | 4 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12: Very Much Improved (n = 40, 25) | 2 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Much Improved (n = 46, 26) | 7 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Much Worse (n = 40, 25) | 1 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Minimally Improved (n = 46, 26) | 10 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Much Improved (n = 40, 25) | 9 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: No Change (n = 46, 26) | 2 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Minimally Worse (n = 40, 25) | 0 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Minimally Worse (n = 46, 26) | 2 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Minimally Improved (n = 40, 25) | 11 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Much Worse (n = 46, 26) | 1 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 : Very Much Worse (n = 40, 25) | 0 Participants |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8: Very Much Worse (n = 46, 26) | 0 Participants |
Secondary
Number of Participants With Categorical Scores on Physician's Global Assessment Scale
Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of effective and ineffective.
Time frame: Week 8 and Week 12
Population: FAS included all participants who received study drug \& had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 8: Effective (n = 46, 26) | 41 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 8: Ineffective (n = 46, 26) | 5 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 12: Effective (n = 40, 25) | 35 Participants |
| Tapentadol | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 12 : Ineffective (n = 40, 25) | 5 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 12 : Ineffective (n = 40, 25) | 5 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 8: Effective (n = 46, 26) | 19 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 12: Effective (n = 40, 25) | 20 Participants |
| Placebo | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Week 8: Ineffective (n = 46, 26) | 7 Participants |
Secondary
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
Participants rated the overall quality of sleep last night as excellent, good, fair and poor.
Time frame: Baseline and Week 12
Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline: Excellent (n=60,31) | 0 Participants |
| Tapentadol | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline: Fair (n=60,31) | 22 Participants |
| Tapentadol | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12 : Good (n=40,25) | 28 Participants |
| Tapentadol | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline: Good (n=60,31) | 35 Participants |
| Tapentadol | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12 : Fair (n=40,25) | 6 Participants |
| Tapentadol | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline: Poor (n=60,31) | 3 Participants |
| Tapentadol | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12 : Poor (n=40,25) | 2 Participants |
| Tapentadol | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12 : Excellent (n=60,31) | 4 Participants |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12 : Poor (n=40,25) | 0 Participants |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline: Excellent (n=60,31) | 1 Participants |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline: Good (n=60,31) | 12 Participants |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline: Fair (n=60,31) | 16 Participants |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline: Poor (n=60,31) | 2 Participants |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12 : Excellent (n=60,31) | 0 Participants |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12 : Good (n=40,25) | 17 Participants |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12 : Fair (n=40,25) | 8 Participants |
Secondary
Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS)
Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.
Time frame: Week 12
Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol | Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Greater than or equal to 30% treatment response | 48.3 Percentage of participants |
| Tapentadol | Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Greater than or equal to 50% treatment response | 33.3 Percentage of participants |
| Placebo | Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Greater than or equal to 30% treatment response | 41.9 Percentage of participants |
| Placebo | Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Greater than or equal to 50% treatment response | 38.7 Percentage of participants |