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| ID | Type | Description | Link |
|---|---|---|---|
| JNS024ER-JPN-N21 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapentadol Hydrochloride | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 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. |
|
| Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
| 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. | Week 12 |
| 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. | Week 8, Week 12 |
| 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". | Week 8, Week 12 |
| 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". | Baseline, Week 12 |
| 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). | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| Week 12 |
| Serum Concentration of Tapentadol | Week 2, 4, 8, 12 |
| Amagasaki |
| Japan |
| Chiba | Japan |
| Chikushi | Japan |
| Edogawa City | Japan |
| Fukuoka | Japan |
| Fukushima | Japan |
| Hiratsuka | Japan |
| Kawasaki | Japan |
| Kōtō City | Japan |
| Matsudo | Japan |
| Meguro City | Japan |
| Minatoku | Japan |
| Niigata | Japan |
| Osaka | Japan |
| Sagamihara | Japan |
| Shibuya City | Japan |
| Shinjuku-Ku | Japan |
| Toshima-Ku | Japan |
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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 |
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| 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. | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
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| 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. | 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. | Posted | Number | Participants | Week 8, Week 12 |
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| 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". | 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. | Posted | Number | Participants | Week 8, Week 12 |
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| 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". | 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. | Posted | Number | Participants | Baseline, Week 12 |
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| 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). | 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. | Posted | Number | Participants | Baseline, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Minutes | Baseline, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Hours | Baseline, Week 12 |
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| 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. | 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. | Posted | Number | Participants | Baseline, Week 12 |
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| 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. | 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. | Posted | Number | Participants | Baseline, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
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| 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. | Safety population included all the participants who received at least 1 dose of the study drug. | Posted | Number | Participants | Week 12 |
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| Other Pre-specified | Serum Concentration of Tapentadol | 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. | Posted | Mean | Standard Deviation | nanogram per milliliter | Week 2, 4, 8, 12 |
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Baseline up to 30 days post last study dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 60 | 54 | 60 | ||
| EG001 | 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. | 0 | 31 | 24 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic dissection | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Respiratory rate increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vascular insufficiency | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
The disclosure restriction on PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager | Neuroscience Department, Clinical Science Department, R&D in Janssen Japan Chiyodaku, Tokyo 101-0065 Japan | +81-3-4411-5509 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077432 | Tapentadol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
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