Back Pain, Low Back Pain, Osteoarthritis, Knee, Pain
Conditions
Keywords
Pain, Low Back Pain, Back Pain, Osteoarthritis, Knee, Tapentadol, Tapentadol Hydrochloride Extended Release
Brief summary
The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.
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), parallel-group (each group of participants will be treated at the same time) comparison study in participants with chronic pain due to osteoarthritis of knee or low back pain. The study duration will be of 14 weeks, which consists of a screening period of 1 week during which the participants will be evaluated for study eligibility, a treatment period of 12 weeks and a follow-up period of 1 week. The treatment period will consist of 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 to the completion of the treatment period). An optimal dose (maintenance dose) will be determined for each participant during the titration period and the treatment will be continued at the maintenance dose to assess the efficacy and safety. Tapentadol hydrochloride ER tablets 25 to 250 milligram or placebo will be administered orally twice daily. Efficacy and safety of the participants will primarily be evaluated by change from baseline in average pain intensity score based on 11-point Numerical Rating Scale (NRS) and Clinical Opiate Withdrawal Scale (COWS), respectively. Participants' safety will be monitored throughout the study.
Interventions
Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
DRUGPlacebo
Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent * Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent * Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent * Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator * Participants who are able to visit the medical institutions throughout the study period
Exclusion criteria
* Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent * Participants with current or a history of epilepsy or seizure disorders * Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy) * Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate) * Participants with moderate to severe liver dysfunction or severe renal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12 | Baseline, Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 11-point Numerical Rating Scale (NRS) | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 | 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. |
| Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS) | Week 12 | 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. |
| Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8, 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 Response Based on Physician's Global Assessment Scale | Week 8, 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 not effective. |
| Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale | Baseline, Week 12 | 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. |
| Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale | Baseline, Week 12 | 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). |
| Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12 | Baseline, Week 12 | 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. |
| Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12 | Baseline, Week 12 | 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. |
| Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12 | Baseline, Week 12 | 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. |
| Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Baseline, Week 12 | 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. |
| Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Baseline, Week 12 | Time slept was addressed by the question: How long did you sleep last night? and the change from Baseline in time slept was reported. |
| Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline, Week 12 | Number of awakenings was addressed by the question: How many times did you wake up during the night?'' and lesser number signified better sleep. |
| Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline, Week 12 | 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. |
| Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Baseline, Week 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Week 12 | 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. |
| Serum Concentration of Tapentadol | Week 2, 4, 8, 12 | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 31 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 1 |
| Overall Study | Disease Progression | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Tapentadol Hydrochloride | Placebo | Total |
|---|---|---|---|
| Age Continuous | 63.6 Years STANDARD_DEVIATION 15.54 | 68.1 Years STANDARD_DEVIATION 13.73 | 65.1 Years STANDARD_DEVIATION 15.03 |
| Sex: Female, Male Female | 42 Participants | 20 Participants | 62 Participants |
| Sex: Female, Male Male | 18 Participants | 11 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 54 / 60 | 24 / 31 |
| serious Total, serious adverse events | 3 / 60 | 0 / 31 |
Outcome results
Primary
Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12 | Baseline | 6.9 Units on a scale | Standard Deviation 1.17 |
| Tapentadol Hydrochloride | 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 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12 | Baseline | 6.9 Units on a scale | Standard Deviation 1.12 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12 | Change at Week 12 | -2.9 Units on a scale | Standard Deviation 2.22 |
95% CI: [-1.04, 0.8]
Secondary
Change From Baseline in 11-point Numerical Rating Scale (NRS)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 2 | -1.1 Units on a scale | Standard Deviation 1.26 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 6 | -2.7 Units on a scale | Standard Deviation 1.9 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 1 | -0.6 Units on a scale | Standard Deviation 1.03 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 8 | -2.8 Units on a scale | Standard Deviation 1.91 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 7 | -2.7 Units on a scale | Standard Deviation 1.86 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 9 | -2.9 Units on a scale | Standard Deviation 1.9 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 3 | -1.5 Units on a scale | Standard Deviation 1.54 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 10 | -2.9 Units on a scale | Standard Deviation 1.98 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 4 | -1.9 Units on a scale | Standard Deviation 1.59 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 11 | -3.0 Units on a scale | Standard Deviation 2.02 |
| Tapentadol Hydrochloride | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 5 | -2.4 Units on a scale | Standard Deviation 1.63 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 11 | -2.9 Units on a scale | Standard Deviation 2.25 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 6 | -2.3 Units on a scale | Standard Deviation 1.82 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 1 | -0.7 Units on a scale | Standard Deviation 1.08 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 3 | -1.6 Units on a scale | Standard Deviation 1.59 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 2 | -1.3 Units on a scale | Standard Deviation 1.55 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 5 | -2.0 Units on a scale | Standard Deviation 1.71 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 7 | -2.6 Units on a scale | Standard Deviation 2.01 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 8 | -2.6 Units on a scale | Standard Deviation 2.08 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 9 | -2.7 Units on a scale | Standard Deviation 2.12 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 10 | -2.8 Units on a scale | Standard Deviation 2.25 |
| Placebo | Change From Baseline in 11-point Numerical Rating Scale (NRS) | Change at Week 4 | -1.8 Units on a scale | Standard Deviation 1.71 |
Secondary
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Placebo | Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12 | Total Score; Baseline (n=60, 31) | 5.7 Units on a scale | Standard Deviation 1.36 |
| Placebo | 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) | -2.3 Units on a scale | Standard Deviation 2.11 |
Secondary
Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Placebo | Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12 | Baseline (n=33, 18) | 12.7 Units on a scale | Standard Deviation 5.35 |
| Placebo | Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12 | Change at Week 12 (n=25, 16) | -1.8 Units on a scale | Standard Deviation 3.04 |
Secondary
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 10.6 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 13.6 |
| Tapentadol Hydrochloride | 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 16.2 |
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| 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=45, 29) | 1.3 Units on a scale | Standard Deviation 15.76 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Functioning; Baseline (n=60, 31) | 51.9 Units on a scale | Standard Deviation 24.65 |
| 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=45, 29) | 3.4 Units on a scale | Standard Deviation 16.26 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Physical; Baseline (n=60, 31) | 57.1 Units on a scale | Standard Deviation 26.41 |
| 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=45, 29) | -0.4 Units on a scale | Standard Deviation 32.13 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Bodily Pain; Baseline (n=60, 31) | 34.3 Units on a scale | Standard Deviation 14.8 |
| 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=45, 29) | 15.1 Units on a scale | Standard Deviation 19.89 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | General Health; Baseline (n=60, 31) | 47.8 Units on a scale | Standard Deviation 18.13 |
| 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=45, 29) | 4.7 Units on a scale | Standard Deviation 14.18 |
| Placebo | 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) | 3.7 Units on a scale | Standard Deviation 17.56 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Social Functioning; Baseline (n=60, 31) | 66.1 Units on a scale | Standard Deviation 23.09 |
| 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=45, 29) | 5.2 Units on a scale | Standard Deviation 32.13 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Role-Emotional; Baseline (n=60, 31) | 61.0 Units on a scale | Standard Deviation 28.25 |
| 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=45, 29) | 2.6 Units on a scale | Standard Deviation 31.58 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Health; Baseline (n=60, 31) | 59.7 Units on a scale | Standard Deviation 20.08 |
| 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=45, 29) | 6.4 Units on a scale | Standard Deviation 19.08 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Mental Summary; Baseline (n=60, 31) | 48.6 Units on a scale | Standard Deviation 9.99 |
| 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=45, 29) | 3.6 Units on a scale | Standard Deviation 8.71 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Physical Summary; Baseline (n=60, 31) | 25.2 Units on a scale | Standard Deviation 16.75 |
| Placebo | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | Vitality; Baseline (n=60, 31) | 51.4 Units on a scale | Standard Deviation 16.67 |
Secondary
Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol Hydrochloride | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | 1.0 Minutes | Standard Deviation 41.06 |
| Placebo | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | 1.2 Minutes | Standard Deviation 31.2 |
Secondary
Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tapentadol Hydrochloride | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | 0.1 Hours | Standard Deviation 1.5 |
| Placebo | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | 0.2 Hours | Standard Deviation 1.04 |
Secondary
Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 |
| Placebo | Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12 | Global Score; Change at Week 12 (n=20, 13) | -0.4 Units on a scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12 | Global Score; Baseline (n=27, 13) | 1.7 Units on a scale | Standard Deviation 0.64 |
Secondary
Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
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
Population: 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 | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 | — |
| Placebo | Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale | Baseline (n=60, 31) | 7 Participants | 1.12 |
| Placebo | Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale | Week 12 (n=45, 29) | 4 Participants | — |
Secondary
Number of Participants With Awakenings Based on Sleep Questionnaire
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
Population: 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 | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 0 awakening (n=60,31) | 10 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 1 awakening (n=60,31) | 18 Participants | 1.55 |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 2 awakenings (n=60,31) | 16 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 3 awakenings (n=60,31) | 10 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 4 awakenings (n=60,31) | 2 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; >= 5 awakenings (n=60,31) | 4 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 0 awakening (n=45,29) | 9 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 1 awakening (n=45,29) | 20 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 2 awakenings (n=45,29) | 9 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 3 awakenings (n=45,29) | 3 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 4 awakenings (n=45,29) | 2 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; >=5 awakenings (n=45,29) | 2 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 4 awakenings (n=45,29) | 1 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 0 awakening (n=60,31) | 6 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 0 awakening (n=45,29) | 6 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 1 awakening (n=60,31) | 6 Participants | 1 |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 3 awakenings (n=45,29) | 7 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 2 awakenings (n=60,31) | 10 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 1 awakening (n=45,29) | 9 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 3 awakenings (n=60,31) | 7 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; >=5 awakenings (n=45,29) | 0 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; 4 awakenings (n=60,31) | 1 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Week 12; 2 awakenings (n=45,29) | 6 Participants | — |
| Placebo | Number of Participants With Awakenings Based on Sleep Questionnaire | Baseline; >= 5 awakenings (n=60,31) | 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, Week 12
Population: 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 | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Much Improved (n = 47, 29) | 17 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Minimally Improved (n = 47, 29) | 12 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; No Change (n = 47, 29) | 2 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Minimally Worse (n = 47, 29) | 1 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Much Worse (n = 47, 29) | 2 Participants | — |
| Tapentadol Hydrochloride | 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 | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; Much Improved (n = 45, 29) | 16 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; Minimally Improved (n = 45, 29) | 9 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; No Change (n = 45, 29) | 4 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 ; Minimally Worse (n = 45, 29) | 0 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; Much Worse (n = 45, 29) | 2 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12 ; Minimally Worse (n = 45, 29) | 2 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Very Much Improved (n = 47, 29) | 5 Participants | 1.12 |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; Very Much Improved (n = 45, 29) | 5 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Much Improved (n = 47, 29) | 9 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; No Change (n = 45, 29) | 5 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Minimally Improved (n = 47, 29) | 9 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; Much Improved (n = 45, 29) | 9 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; No Change (n = 47, 29) | 4 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; Much Worse (n = 45, 29) | 0 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Minimally Worse (n = 47, 29) | 2 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 12; Minimally Improved (n = 45, 29) | 8 Participants | — |
| Placebo | Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale | Week 8; Much Worse (n = 47, 29) | 0 Participants | — |
Secondary
Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale
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
Population: 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 | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale | Week 12 (n=45, 29) | 25 Participants | — |
| Placebo | Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale | Baseline (n=60,31) | 25 Participants | 1.12 |
| Placebo | Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale | Week 12 (n=45, 29) | 21 Participants | — |
Secondary
Number of Participants With Response Based on Overall Quality of Sleep Questionnaire
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
Population: 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 | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline; Excellent (n=60, 31) | 1 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline; Good (n=60, 31) | 37 Participants | 1.55 |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline; Fair (n=60, 31) | 19 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline; Poor (n=60, 31) | 3 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12; Excellent (n=45, 29) | 2 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12; Good (n=45, 29) | 30 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12; Fair (n=45, 29) | 9 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12; Poor (n=45, 29) | 4 Participants | — |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12; Poor (n=45, 29) | 1 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 | Week 12; Excellent (n=45, 29) | 0 Participants | — |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline; Good (n=60, 31) | 17 Participants | 1 |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12; Fair (n=45, 29) | 7 Participants | — |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline; Fair (n=60, 31) | 13 Participants | — |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Week 12; Good (n=45, 29) | 21 Participants | — |
| Placebo | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Baseline; Poor (n=60, 31) | 0 Participants | — |
Secondary
Number of Participants With Response Based 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 not effective.
Time frame: Week 8, Week 12
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tapentadol Hydrochloride | Number of Participants With Response Based on Physician's Global Assessment Scale | Week 8; Effective (n=47, 29) | 41 Participants |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Physician's Global Assessment Scale | Week 8; Not effective (n=47, 29) | 6 Participants |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Physician's Global Assessment Scale | Week 12; Effective (n=45, 29) | 40 Participants |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Physician's Global Assessment Scale | Week 12; Not effective (n=45, 29) | 5 Participants |
| Placebo | Number of Participants With Response Based on Physician's Global Assessment Scale | Week 12; Not effective (n=45, 29) | 8 Participants |
| Placebo | Number of Participants With Response Based on Physician's Global Assessment Scale | Week 8; Effective (n=47, 29) | 24 Participants |
| Placebo | Number of Participants With Response Based on Physician's Global Assessment Scale | Week 12; Effective (n=45, 29) | 21 Participants |
| Placebo | Number of Participants With Response Based on Physician's Global Assessment Scale | Week 8; Not effective (n=47, 29) | 5 Participants |
Secondary
Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)
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
Population: FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | 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 |
| Tapentadol Hydrochloride | 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 | — |
| Placebo | Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS) | Greater than or equal to 30 percent improvement | 61.3 Percentage of participants | 95% Confidence Interval 1.12 |
| Placebo | Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS) | Greater than or equal to 50 percent improvement | 48.4 Percentage of participants | — |
Other Pre-specified
Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)
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
Population: Safety population included all the participants who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Mild | 0 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Moderately Severe | 0 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Moderate | 0 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Severe Withdrawal | 0 Participants | — |
| Tapentadol Hydrochloride | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | No Withdrawal | 60 Participants | 1.17 |
| Placebo | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Severe Withdrawal | 0 Participants | — |
| Placebo | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | No Withdrawal | 31 Participants | 1.12 |
| Placebo | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Mild | 0 Participants | — |
| Placebo | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Moderate | 0 Participants | — |
| Placebo | Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS) | Moderately Severe | 0 Participants | — |
Other Pre-specified
Serum Concentration of Tapentadol
Time frame: Week 2, 4, 8, 12
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 25 mg Week 2, n=11 | 14.1 nanogram per milliliter | Standard Deviation 6.02 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 25 mg Week 12, n=3 | 29.2 nanogram per milliliter | Standard Deviation 13.2 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 50 mg Week 12, n=8 | 25.1 nanogram per milliliter | Standard Deviation 8.17 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 50 mg Week 2, n=48 | 29.7 nanogram per milliliter | Standard Deviation 17.1 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 100 mg Week 2, n=1 | 47.9 nanogram per milliliter | — |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 150 mg Week 2, n=0 | NA nanogram per milliliter | — |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 200 mg Week 2, n=0 | NA nanogram per milliliter | — |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 250 mg Week 2, n=0 | NA nanogram per milliliter | — |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 25 mg Week 4, n=4 | 22.8 nanogram per milliliter | Standard Deviation 11.6 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 50 mg Week 4, n=10 | 23.6 nanogram per milliliter | Standard Deviation 6.2 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 100 mg Week 4, n=28 | 59.0 nanogram per milliliter | Standard Deviation 42.7 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 150 mg Week 4, n=16 | 76.2 nanogram per milliliter | Standard Deviation 48.5 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 200 mg Week 4, n=0 | NA nanogram per milliliter | — |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 250 mg Week 4, n=0 | NA nanogram per milliliter | — |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 25 mg Week 8, n=3 | 25.1 nanogram per milliliter | Standard Deviation 15.3 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 50 mg Week 8, n=8 | 22.7 nanogram per milliliter | Standard Deviation 12.2 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 100 mg Week 8, n=16 | 57.7 nanogram per milliliter | Standard Deviation 40.7 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 150 mg Week 8, n=13 | 83.2 nanogram per milliliter | Standard Deviation 35.9 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 200 mg Week 8, n=4 | 87.8 nanogram per milliliter | Standard Deviation 58.9 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 250 mg Week 8, n=4 | 147 nanogram per milliliter | Standard Deviation 119 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 100 mg Week 12, n=14 | 49.1 nanogram per milliliter | Standard Deviation 36.3 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 150 mg Week 12, n=12 | 40.4 nanogram per milliliter | Standard Deviation 33.9 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 200 mg Week 12, n=4 | 119 nanogram per milliliter | Standard Deviation 165 |
| Tapentadol Hydrochloride | Serum Concentration of Tapentadol | Tapentadol Hydrochloride 250 mg Week 12, n=4 | 130 nanogram per milliliter | Standard Deviation 77.6 |