Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JNS013-JPN-04 | |||
| NCT00736853 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen (Open-Label) | Experimental |
| |
| Tramadol Hydrochloride Plus Acetaminophen (Double Blind) | Experimental |
| |
| Placebo (Double-Blind) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen (Open-Label) | Drug | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period | The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief. | Day 28 of double-blind period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period | Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement. | Day 1 of open-label period and Day 1 of double-blind period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi | Japan | |||||
Not provided
| Label | URL |
|---|---|
| A Phase III Study of JNS013 in Patients with Chronic Pain | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tramadol Hydrochloride and Acetaminophen (Open-Label) | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) | Drug | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks. |
|
| Placebo (Double-Blind) | Drug | Matching placebo will be given up to 4 weeks. |
|
| Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period | Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement. | Day 1 and Day 28 of double-blind period |
| Mean Pain Intensity (PI) Score During Open-Label Period | PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain. | Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period |
| Mean PI Score During Double-Blind Period | The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain. | Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period |
| Mean Pain Intensity Difference (PID) During the Open-Label Period | The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. | Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period |
| Mean PID During the Double-Blind Period | The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. | Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period |
| Mean Pain Relief (PAR) Score During the Open-Label Period | PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. | 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period |
| Mean PAR Score During the Double-Blind Period | PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. | 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period |
| Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period | The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief. | 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period |
| Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period | The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief. | 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period |
| Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period | The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. | Day 1, and Day 8 of open-label period |
| Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period | The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. | Day 1, 8, 15, 22 and 28 of double-blind period |
| Total Pain Relief (TOTPAR) Score During the Open-Label Period | The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief. | Day 1 and Day 8 of open-label period |
| Total Pain Relief (TOTPAR) Score During the Double-Blind Period | The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief. | Day 1, 8, 15, 22 and 28 of double-blind period |
| Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period | The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief. | Day 1, and Day 8 of open-label period |
| Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period | The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. | Day 1, 8, 15, 22 and 28 of double-blind period |
| Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period | The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability. | Day 1 and Day 14 of open-label period |
| Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period | The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability. | Day 1 and Day 28 of double-blind period |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period | The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL. | Day 1 and Day 14 of open-label period |
| Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period | The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL. | Day 1 and Day 28 of double-blind period |
| Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period | The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status. | Day 1 and Day 14 of open-label period |
| Change From Baseline in SF-36 at Day 28 of Double-Blind Period | The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status. | Day 1 and Day 28 of double-blind period |
| Amagasaki |
| Japan |
| Chiba | Japan |
| Edogawa City | Japan |
| Fukuoka | Japan |
| Fukushima | Japan |
| Iruma | Japan |
| Kagoshima | Japan |
| Kawasaki | Japan |
| Kumagaya | Japan |
| Kurume | Japan |
| Meguro City | Japan |
| Minato | Japan |
| Niigata | Japan |
| Ohta-Ku | Japan |
| Okazaki | Japan |
| Sagamihara | Japan |
| Setagaya City | Japan |
| Shibuya City | Japan |
| Shinjuku-Ku | Japan |
| Tramadol Hydrochloride and Acetaminophen (Double-Blind) |
Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. |
| FG002 | Placebo (Double-Blind) | Matching placebo was given up to 4 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets) during the open-label period. Participants received placebo or fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg (same dose which was used in second week of open-label period) in double-blind period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Efficacy analysis set: Participants who received at least 1 dose of study drug. | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | Efficacy analysis set: Participants who received at least 1 dose of study drug. | 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 | Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period | The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief. | Efficacy analysis set included participants who received at least one dose of the study drug. | Posted | Number | number of participants | Day 28 of double-blind period |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period | Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement. | Efficacy analysis set included participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | mm | Day 1 of open-label period and Day 1 of double-blind period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period | Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement. | Efficacy analysis set included participants who received at least one dose of the study drug. | Posted | Mean | Standard Deviation | mm | Day 1 and Day 28 of double-blind period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Intensity (PI) Score During Open-Label Period | PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain. | Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. | Posted | Mean | Standard Deviation | units on a scale | Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean PI Score During Double-Blind Period | The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain. | Efficacy analysis set included participants who received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Intensity Difference (PID) During the Open-Label Period | The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. | Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. | Posted | Mean | Standard Deviation | units on a scale | Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean PID During the Double-Blind Period | The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. | Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Pain Relief (PAR) Score During the Open-Label Period | PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. | Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. | Posted | Mean | Standard Deviation | units on a scale | 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean PAR Score During the Double-Blind Period | PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. | Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period | The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief. | Efficacy analysis set included who received at least one dose of study medication. Here 'n' signifies number of participants evaluable for each time point. | Posted | Mean | Standard Deviation | units on a scale | 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period | The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief. | Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period | The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. | Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1, and Day 8 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period | The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. | Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1, 8, 15, 22 and 28 of double-blind period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Pain Relief (TOTPAR) Score During the Open-Label Period | The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief. | Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 8 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Pain Relief (TOTPAR) Score During the Double-Blind Period | The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief. | Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1, 8, 15, 22 and 28 of double-blind period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period | The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief. | Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1, and Day 8 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period | The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. | Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1, 8, 15, 22 and 28 of double-blind period |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period | The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability. | Efficacy analysis set included who received at least one dose of study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 14 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period | The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability. | Efficacy analysis set included participants received at least one dose of the study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 28 of double-blind period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period | The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL. | Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 14 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period | The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL. | Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 28 of double-blind period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period | The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status. | Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 14 of open-label period |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in SF-36 at Day 28 of Double-Blind Period | The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status. | Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. | Posted | Mean | Standard Deviation | units on a scale | Day 1 and Day 28 of double-blind period |
|
|
From the start of open-label period until 7 days after the last dose of study medication
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tramadol Hydrochloride and Acetaminophen (Open-Label) | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). | 0 | 277 | 222 | 277 | ||
| EG001 | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | 1 | 94 | 47 | 94 | ||
| EG002 | Placebo (Double-Blind) | Matching placebo was given up to 4 weeks. | 0 | 93 | 44 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J V11.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Sty | Infections and infestations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Loss of appetite | Metabolism and nutrition disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Attention deficit | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Hypoesthesia | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Tremors | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Positional vertigo | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Rotatory vertigo | Ear and labyrinth disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blushing | Vascular disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Gastric discomfort | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Upper abdominal pain | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Indigestion | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Abnormal gastrointestinal sounds | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Liver function abnormality | Hepatobiliary disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Excessive perspiration | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Exanthema | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Allergic pruritus | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Ingrown nail | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Systemic pruritus | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Leg mass | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Urination disorder | Renal and urinary disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Ischuria | Renal and urinary disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Abnormal sensation | General disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Dry mouth | General disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Lassitude | General disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Fever | General disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| γ-glutamyl transferase increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood pressure elevated | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Urine glucose positive | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Urine blood positive | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood creatinine decreased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Eosinophil fraction increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Neutrophil fraction increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Lymphocyte fraction decreased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Urine protein positive | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Fall/tumble | Injury, poisoning and procedural complications | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Traffic accident | Injury, poisoning and procedural complications | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Blood K increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Hemoglobin decreased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Lipids increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Liver function test abnormality | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Weight loss | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Kidney function test abnormality | Investigations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Convulsions | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Abnormal sensation in the eye | Eye disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Vision impairment | Eye disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Upper respiratory inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA/J V11.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA/J V11.1 | Non-systematic Assessment |
|
The only disclosure restriction on the PIs is that the Sponsor can review results communications prior to public release.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Neuroscience Department, Clinical Science Division, R&D, JANSSEN PHARMACEUTICAL. K.K. | +81-3-4411-5509 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D020370 | Osteoarthritis, Knee |
| D017116 | Low Back Pain |
| 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 |
| D001416 | Back Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| D004311 | Double-Blind Method |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided
| Withdrawal by Subject |
|
| Ineligible to participate the study |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
| Participants |
|
|