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| ID | Type | Description | Link |
|---|---|---|---|
| JNS024ER-JPN-N22 |
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The purpose of this study is to investigate the efficacy and safety of tapentadol extended-release (ER) tablets in Japanese participants with moderate to severe chronic (lasting a long time) pain due to painful diabetic peripheral neuropathy (pain in the extremities related to diabetes-induced nerve damage) or postherpetic neuralgia (pain lasting after condition has healed).
This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), and parallel-group (each group of participant will be treated at the same time) comparison study in Japanese participants with chronic pain due to painful diabetic peripheral neuropathy or postherpetic neuralgia. The duration of study will be 14 weeks. The study consists of 3 parts: Screening (1 Week before study commences on Day 1); Treatment (12 weeks and will include titration period [from the initiation of the study treatment to determination of the individual's maintenance dose] and maintenance period [from completion of the titration period up to12 week]); and Follow-up (1 Week). Tapentadol hydrochloride ER oral tablet or matching placebo will be administered twice daily for 12 weeks. Efficacy of the participants will primarily be evaluated through Numerical Rating Scale (NRS). Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapentadol | Experimental | Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. |
|
| Placebo | Placebo Comparator | Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapentadol | Drug | Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chigasaki | Japan | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tapentadol | Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks. |
|
| Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
| Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. | 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 and Week 12 |
| Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "ineffective". | Week 8 and Week 12 |
| Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. | Baseline and Week 12 |
| Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent [no pain]) to 10 (extreme [pain as bad as you can image]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. | Baseline and Week 12 |
| Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. | Baseline and Week 12 |
| Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Sleep Latency was related to "How long after bedtime or lights out did the participant fall asleep last night ". Decrease in time indicates an improvement. | Baseline and Week 12 |
| Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Time slept was related to "How long did the participant sleep last night". The mean change for the time in hours slept during the last night was reported. | Baseline and Week 12 |
| Number of Participants With Awakenings Based on Sleep Questionnaire | Number of awakenings was related to "How many times did the participant wake up during the night". Lesser number signifies better sleep. | Baseline and Week 12 |
| Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Participants rated the overall quality of sleep last night as excellent, good, fair and poor. | Baseline and Week 12 |
| Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. | Baseline and Week 12 |
| Chūōku |
| Japan |
| Fukuoka | Japan |
| Inashiki | Japan |
| Isesaki | Japan |
| Izumisano | Japan |
| Kanuma | Japan |
| Katsushika-ku | Japan |
| Kawaguchi | Japan |
| kooriyama | Japan |
| Kurume | Japan |
| Kyoto | Japan |
| Matsue | Japan |
| Matsumoto | Japan |
| Minatoku | Japan |
| Mitaka | Japan |
| Nagano | Japan |
| Nagoya | Japan |
| Obihiro | Japan |
| Ohta-Ku | Japan |
| Ohtsu | Japan |
| Okayama | Japan |
| Omuta | Japan |
| Osaka | Japan |
| Sapporo | Japan |
| Sendai | Japan |
| Setagaya City | Japan |
| Shimotsuga | Japan |
| Tokyo | Japan |
| Ube | Japan |
| Yokohama | Japan |
Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tapentadol | Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. |
| BG001 | Placebo | Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 12 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at Week 12 minus mean NRS score at Baseline. | Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
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| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Numerical Rating Scale (NRS) Score at Week 1 to 11 | Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number on the scale applicable to their pain. Baseline pain score is defined as the average pain intensity score over the last 3 days prior to the randomization. Change from Baseline in NRS score is the mean NRS score at corresponding week minus mean NRS score at Baseline. | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Response Based on Numerical Rating Scale (NRS) | Percentage of participants with treatment response in mean NRS score by greater than equal to 30 or 50 percent (%) in the last week from baseline were considered as responders. Participants were asked to assess the average pain intensity on an 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. | Posted | Number | Percentage of participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||
| 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 & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | Week 8 and Week 12 |
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Categorical Scores on Physician's Global Assessment Scale | Physician's Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "ineffective". | FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | Week 8 and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain Interference Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain interference sub-scale score ranges from 0 (do not interfere) to 10 (completely interferes). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. | FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain Subscale Score Based on Brief Pain Inventory (Short Form) (BPI-sf) Scale | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Pain Sub-scale score ranges from 0 (absent [no pain]) to 10 (extreme [pain as bad as you can image]). Higher scores indicates worsening. Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. | FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Brief Pain Inventory (Short Form) (BPI-sf) Total Score at Week 12 | The BPI-sf consists of 15 Items (Item 1:presence of pain; Item 2:pain location; Items 3 to 6:pain severity; Item 7:status of pain treatment; Item 8:efficacy of pain treatment; and Items 9a to 9g: interference of pain with daily life). Total score is defined as the mean scores from Items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Lower score indicates an improvement in pain. | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
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| Secondary | Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12 | Sleep Latency was related to "How long after bedtime or lights out did the participant fall asleep last night ". Decrease in time indicates an improvement. | FAS included all participants who received study drug & had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure & 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Minutes | Baseline and Week 12 |
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| Secondary | Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12 | Time slept was related to "How long did the participant sleep last night". The mean change for the time in hours slept during the last night was reported. | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Hours | Baseline and Week 12 |
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| Secondary | Number of Participants With Awakenings Based on Sleep Questionnaire | Number of awakenings was related to "How many times did the participant wake up during the night". Lesser number signifies better sleep. | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | Baseline and Week 12 |
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| Secondary | Number of Participants With Response Based on Overall Quality of Sleep Questionnaire | Participants rated the overall quality of sleep last night as excellent, good, fair and poor. | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | Baseline and Week 12 |
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| Secondary | Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12 | The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. | FAS included all the randomly assigned participants who received at least 1 dose of study drug and had at least 1 post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
|
Baseline up to Week 12
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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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 | Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks. | 4 | 60 | 52 | 60 | ||
| EG001 | Placebo | Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks. | 3 | 31 | 26 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Drug withdrawal syndrome | General 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 |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Listless | 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 |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Radial nerve palsy | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
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| 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 |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Xeroderma | 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 |
| |
| Pruritus | 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 |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back pain | 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 |
| |
| Pain in extremity | 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 |
| |
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Electrocardiogram ST segment depression | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Eosinophil percentage increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Lymphocyte percentage decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
Not provided
| 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 |
| D003929 | Diabetic Neuropathies |
| D009437 | Neuralgia |
| D051474 | Neuralgia, Postherpetic |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System 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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