A Phase 3 interventional study of Tramadol Hydrochloride Plus Acetaminophen (Open-Label) and Tramadol Hydrochloride Plus Acetaminophen (Double-Blind) in Pain, sponsored by Janssen Pharmaceutical K.K.. Completed at 22 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-09-26.
Sponsored by Janssen Pharmaceutical K.K. · Phase 3, Interventional, and Treatment
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.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 321 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Janssen Pharmaceutical K.K. is the lead sponsor of 122 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
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Exclusion Criteria:
Drug: Tramadol Hydrochloride Plus Acetaminophen (Open-Label)
Drug: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)
Drug: Placebo (Double-Blind)
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).
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.
Matching placebo will be given up to 4 weeks.
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.
Time frame: Day 28 of double-blind period
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.
Time frame: Day 1 of open-label period and Day 1 of double-blind period
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 and Day 28 of double-blind period
| Milestone | Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|---|
| Started | 319 | 0 | 0 |
| Treated | 277 | 0 | 0 |
| Completed | 187 | 0 | 0 |
| Not completed | 132 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 |
| Withdrew: Adverse event | 31 | 0 | 0 |
| Withdrew: Withdrawal by subject | 16 | 0 | 0 |
| Withdrew: Started but not treated | 42 | 0 | 0 |
| Withdrew: Failed to meet the transfer criteria | 40 | 0 | 0 |
| Withdrew: Unable to attend hospital appointments | 1 | 0 | 0 |
| Milestone | Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|---|
| Started | 0 | 94 | 93 |
| Completed | 0 | 70 | 45 |
| Not completed | 0 | 24 | 48 |
| Withdrew: Lack of efficacy | 0 | 19 | 42 |
| Withdrew: Adverse event | 0 | 3 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 | 4 |
| Withdrew: Ineligible to participate the study | 0 | 1 | 0 |
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.
| number of participants | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period | 20 | 43 |
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.
| mm | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1 of open-label period | 66.27 ± 13.69 |
| Change at Day 1 of double-blind period | -28.17 ± 21.16 |
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.
| mm | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1 | 30.33 ± 17.47 | 31.18 ± 16.59 |
| Change at Day 28 | -0.67 ± 18.14 | 6.21 ± 22.50 |
PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1; Pre-dose (n=275) | 1.7 ± 0.56 |
| Day 1; 2 hours after dosing (n=274) | 1.2 ± 0.62 |
| Day 1; 4 hours after dosing (n=274) | 1.1 ± 0.65 |
| Day 8; Pre-dose (n=219) | 1.2 ± 0.43 |
| Day 8; 2 hours after dosing (n=219) | 1.0 ± 0.49 |
| Day 8; 4 hours after dosing (n=219) | 0.9 ± 0.55 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1; Pre-dose (n=84, 89) | 1.2 ± 0.37 | 1.2 ± 0.37 |
| Day 1; 2 hours after dosing (n=84, 89) | 1.0 ± 0.44 | 1.1 ± 0.43 |
| Day 1; 4 hours after dosing (n=84, 89) | 1.0 ± 0.49 | 1.1 ± 0.47 |
| Day 8; Pre-dose (n=74, 48) | 1.2 ± 0.39 | 1.2 ± 0.42 |
| Day 8; 2 hours after dosing (n=74, 48) | 1.0 ± 0.47 | 1.1 ± 0.58 |
| Day 8; 4 hours after dosing (n=74, 48) | 0.9 ± 0.51 | 1.1 ± 0.43 |
| Day 15; Pre-dose (n=67, 41) | 1.1 ± 0.33 | 1.1 ± 0.33 |
| Day 15; 2 hours after dosing (n=67, 41) | 1.0 ± 0.46 | 1.0 ± 0.50 |
| Day 15; 4 hours after dosing (n=67, 41) | 0.8 ± 0.51 | 0.9 ± 0.52 |
| Day 22; Pre-dose (n=63, 40) | 1.1 ± 0.30 | 1.2 ± 0.38 |
| Day 22, 2 hours after dosing (n=63, 40) | 1.0 ± 0.42 | 1.0 ± 0.50 |
| Day 22; 4 hours after dosing (n=63, 40) | 0.9 ± 0.49 | 1.0 ± 0.50 |
| Day 28; Pre-dose (n=72, 47) | 1.1 ± 0.33 | 1.2 ± 0.41 |
| Day 28; 2 hours after dosing (n=72, 47) | 1.0 ± 0.44 | 1.0 ± 0.51 |
| Day 28; 4 hours after dosing (n=72, 47) | 0.9 ± 0.50 | 1.0 ± 0.49 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1; 2 hours after dosing (n=274) | 0.4 ± 0.59 |
| Day 1; 4 hours after dosing (n=274) | 0.5 ± 0.66 |
| Day 8; 2 hours after dosing (n=219) | 0.2 ± 0.50 |
| Day 8; 4 hours after dosing (n=219) | 0.3 ± 0.52 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1; 2 hours after dosing (n=84, 89) | 0.2 ± 0.40 | 0.1 ± 0.34 |
| Day 1; 4 hours after dosing (n=84, 89) | 0.2 ± 0.49 | 0.1 ± 0.42 |
| Day 8; 2 hours after dosing (n=74, 48) | 0.2 ± 0.39 | 0.1 ± 0.46 |
| Day 8; 4 hours after dosing (n=74, 48) | 0.3 ± 0.50 | 0.2 ± 0.38 |
| Day 15; 2 hours after dosing (n=67, 41) | 0.1 ± 0.36 | 0.2 ± 0.44 |
| Day 15; 4 hours after dosing (n=67, 41) | 0.3 ± 0.49 | 0.2 ± 0.51 |
| Day 22; 2 hours after dosing (n=63, 40) | 0.1 ± 0.35 | 0.2 ± 0.42 |
| Day 22; 4 hours after dosing (n=63, 40) | 0.2 ± 0.42 | 0.2 ± 0.42 |
| Day 28; 2 hours after dosing (n=72, 47) | 0.2 ± 0.36 | 0.2 ± 0.41 |
| Day 28; 4 hours after dosing (n=72, 47) | 0.3 ± 0.44 | 0.2 ± 0.43 |
PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1; 2 hours after dosing (n=274) | 1.2 ± 0.97 |
| Day 1; 4 hours after dosing (n=274) | 1.4 ± 1.01 |
| Day 8; 2 hours after dosing (n=219) | 1.7 ± 1.03 |
| Day 8; 4 hours after dosing (n=219) | 1.8 ± 1.02 |
PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1; 2 hours after dosing (n=84, 89) | 1.7 ± 1.02 | 1.1 ± 1.04 |
| Day 1; 4 hours after dosing (n=84, 89) | 1.8 ± 1.01 | 1.2 ± 1.00 |
| Day 8; 2 hours after dosing (n=74, 48) | 1.9 ± 1.06 | 1.2 ± 1.08 |
| Day 8; 4 hours after dosing (n=74, 48) | 1.9 ± 1.01 | 1.4 ± 1.05 |
| Day 15; 2 hours after dosing (n=67, 41) | 2.1 ± 1.09 | 1.7 ± 1.11 |
| Day 15; 4 hours after dosing (n=67, 41) | 2.1 ± 1.00 | 1.7 ± 1.06 |
| Day 22; 2 hours after dosing (n=63, 40) | 2.1 ± 0.96 | 1.8 ± 1.21 |
| Day 22; 4 hours after dosing (n=63, 40) | 2.2 ± 1.00 | 1.8 ± 1.26 |
| Day 28; 2 hours after dosing (n=72, 47) | 2.1 ± 1.00 | 1.6 ± 1.26 |
| Day 28; 4 hours after dosing (n=72, 47) | 2.1 ± 1.04 | 1.7 ± 1.29 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1; 2 hours after dosing (n=274) | 1.6 ± 1.39 |
| Day 1; 4 hours after dosing (n=274) | 1.9 ± 1.49 |
| Day 8; 2 hours after dosing (n=219) | 1.9 ± 1.30 |
| Day 8; 4 hours after dosing (n=219) | 2.2 ± 1.36 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1; 2 hours after dosing (n=84, 89) | 1.9 ± 1.20 | 1.2 ± 1.19 |
| Day 1; 4 hours after dosing (n=84, 89) | 2.0 ± 1.28 | 1.2 ± 1.18 |
| Day 8; 2 hours after dosing (n=74, 48) | 2.1 ± 1.23 | 1.4 ± 1.36 |
| Day 8; 4 hours after dosing (n=74, 48) | 2.3 ± 1.22 | 1.6 ± 1.25 |
| Day 15; 2 hours after dosing (n=67, 41) | 2.2 ± 1.29 | 1.8 ± 1.39 |
| Day 15; 4 hours after dosing (n=67, 41) | 2.4 ± 1.27 | 1.9 ± 1.35 |
| Day 22; 2 hours after dosing (n=63, 40) | 2.3 ± 1.10 | 2.0 ± 1.46 |
| Day 22; 4 hours after dosing (n=63, 40) | 2.4 ± 1.24 | 2.1 ± 1.45 |
| Day 28; 2 hours after dosing (n=72, 47) | 2.2 ± 1.14 | 1.8 ± 1.52 |
| Day 28; 4 hours after dosing (n=72, 47) | 2.4 ± 1.28 | 1.9 ± 1.49 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1 (n=274) | 0.9 ± 1.17 |
| Day 8 (n=219) | 0.5 ± 0.93 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1 (n=84, 89) | 0.4 ± 0.79 | 0.1 ± 0.70 |
| Day 8 (n=74, 48) | 0.5 ± 0.81 | 0.3 ± 0.78 |
| Day 15 (n=67, 41) | 0.4 ± 0.76 | 0.4 ± 0.86 |
| Day 22 (n=63, 40) | 0.4 ± 0.73 | 0.5 ± 0.78 |
| Day 28 (n=72, 47) | 0.4 ± 0.74 | 0.4 ± 0.77 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1 (n=274) | 2.6 ± 1.89 |
| Day 8 (n=219) | 3.5 ± 1.95 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1 (n=84, 89) | 3.5 ± 1.97 | 2.3 ± 2.00 |
| Day 8 (n=74, 48) | 3.8 ± 2.00 | 2.6 ± 2.05 |
| Day 15 (n=67, 41) | 4.1 ± 2.04 | 3.3 ± 2.10 |
| Day 22 (n=63, 40) | 4.3 ± 1.91 | 3.6 ± 2.42 |
| Day 28 (n=72, 47) | 4.2 ± 1.99 | 3.3 ± 2.50 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1 (n=274) | 3.5 ± 2.74 |
| Day 8 (n=219) | 4.1 ± 2.50 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1 (n=84, 89) | 3.9 ± 2.37 | 2.4 ± 2.30 |
| Day 8 (n=74, 48) | 4.3 ± 2.32 | 3.0 ± 2.48 |
| Day 15 (n=67, 41) | 4.6 ± 2.46 | 3.7 ± 2.61 |
| Day 22 (n=63, 40) | 4.7 ± 2.27 | 4.0 ± 2.81 |
| Day 28 (n=72, 47) | 4.6 ± 2.35 | 3.7 ± 2.90 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1 (n=160) | 9.1 ± 4.89 |
| Change at Day 14 (n=126) | -2.6 ± 3.28 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1 (n=55, 57) | 6.5 ± 4.41 | 6.0 ± 4.57 |
| Change at Day 28 (n=55, 57) | -0.5 ± 3.08 | 0.8 ± 3.69 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1; Pain (n=117) | 4.4 ± 1.96 |
| Change at Day 14; Pain (n=90) | -1.9 ± 1.66 |
| Day 1; Stiffness (n=117) | 4.2 ± 2.31 |
| Change at Day 14; Stiffness (n=90) | -1.5 ± 2.09 |
| Day 1; EODA (n=117) | 3.7 ± 1.89 |
| Change at Day 14; EODA (n=90) | -1.5 ± 1.38 |
| Day 1; General index (n=117) | 4.1 ± 1.82 |
| Change at Day 14; General index (n=90) | -1.7 ± 1.39 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1; Pain (n=39, 36) | 2.6 ± 1.46 | 2.2 ± 1.20 |
| Change at Day 28; Pain (n=39, 36) | -0.3 ± 1.02 | 0.5 ± 1.49 |
| Day 1; Stiffness (n=39, 36) | 2.7 ± 1.94 | 2.4 ± 1.72 |
| Change at Day 28; Stiffness (n=39, 36) | -0.2 ± 1.33 | 0.2 ± 1.99 |
| Day 1; EODA (n=39, 36) | 2.3 ± 1.68 | 1.9 ± 1.45 |
| Change at Day 28; EODA (n=39, 36) | -0.5 ± 0.58 | 0.4 ± 1.30 |
| Day 1; General index (n=39, 36) | 2.5 ± 1.48 | 2.2 ± 1.23 |
| Change at Day 28; General index (n=39, 36) | -0.4 ± 0.65 | 0.4 ± 1.29 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Day 1; Physical functioning (n=277) | 34.3 ± 15.23 |
| Change at Day 14; Physical functioning (n=216) | 3.9 ± 10.39 |
| Day 1; Role-physical (n=216) | 37.0 ± 13.62 |
| Change at Day 14; Role-physical (n=216) | 4.3 ± 11.10 |
| Day 1; Bodily pain (n=277) | 34.8 ± 6.59 |
| Change at Day 14; Bodily pain (n=216) | 5.4 ± 7.04 |
| Day 1; General health (n=277) | 45.4 ± 9.01 |
| Change at Day 14; General health (n=216) | 2.7 ± 6.31 |
| Day 1; Vitality (n=277) | 45.1 ± 9.43 |
| Change at Day 14; Vitality (n=216) | 2.3 ± 8.10 |
| Day 1; Social functioning (n=277) | 43.5 ± 12.48 |
| Change at Day 14; Social functioning (n=277) | 2.0 ± 10.76 |
| Day 1; Role-emotional (n=277) | 43.2 ± 12.95 |
| Change at Day 14; Role-emotional (n=216) | 2.5 ± 11.36 |
| Day 1; Mental health (n=277) | 46.8 ± 9.69 |
| Change at Day 14; Mental health (n=216) | 2.8 ± 8.59 |
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.
| units on a scale | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Day 1; Physical functioning (n=94,93) | 39.0 ± 12.28 | 39.7 ± 13.36 |
| Change at Day 28; Physical functioning (n=94,93) | 1.1 ± 8.49 | -1.6 ± 10.03 |
| Day 1; Role-physical (n=94,93) | 40.5 ± 12.84 | 41.8 ± 12.24 |
| Change at Day 28; Role-physical (n=94,93) | 0.8 ± 11.87 | -0.6 ± 9.54 |
| Day 1; Bodily pain (n=94,93) | 41.0 ± 7.68 | 39.3 ± 7.27 |
| Change at Day 28; Bodily pain (n=94,93) | 2.4 ± 7.24 | 0.3 ± 7.77 |
| Day 1; General health (n=94,93) | 49.1 ± 9.23 | 48.0 ± 9.33 |
| Change at Day 28; General health (n=94,93) | 0.4 ± 7.11 | -1.2 ± 5.97 |
| Day 1; Vitality (n=94,93) | 47.3 ± 9.58 | 47.4 ± 8.49 |
| Change at Day 28; Vitality (n=94,93) | 3.1 ± 7.40 | 0.1 ± 7.51 |
| Day 1; Social functioning (n=94,93) | 46.4 ± 12.68 | 45.7 ± 11.48 |
| Change at Day 28; Social functioning (n=94,93) | 1.6 ± 11.32 | 0.4 ± 10.07 |
| Day 1; Role-emotional (n=94,93) | 46.7 ± 11.46 | 45.8 ± 11.72 |
| Change at Day 28; Role-emotional (n=94,93) | 0.0 ± 9.49 | -1.0 ± 9.99 |
| Day 1; Mental health (n=94,93) | 50.4 ± 9.14 | 49.6 ± 8.80 |
| Change at Day 28; Mental health (n=94,93) | 2.2 ± 7.29 | -0.7 ± 8.17 |
Collected over From the start of open-label period until 7 days after the last dose of study medication. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tramadol Hydrochloride and Acetaminophen (Open-Label) | — | 0/277 (0%) | 222/277 (80.1%) |
| Tramadol Hydrochloride and Acetaminophen (Double-Blind) | — | 1/94 (1.1%) | 47/94 (50%) |
| Placebo (Double-Blind) | — | 0/93 (0%) | 44/93 (47.3%) |
| Event | Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|---|
| Rectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/277 | 1/94 | 0/93 |
| Event | Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|---|
| NauseaGastrointestinal disorders | 125/277 | 5/94 | 3/93 |
| SomnolenceNervous system disorders | 77/277 | 1/94 | 2/93 |
| VomitingGastrointestinal disorders | 76/277 | 1/94 | 1/93 |
| ConstipationGastrointestinal disorders | 52/277 | 3/94 | 0/93 |
| NasopharyngitisInfections and infestations | 6/277 | 5/94 | 17/93 |
| DizzinessNervous system disorders | 45/277 | 3/94 | 0/93 |
| γ-glutamyl transferase increasedInvestigations | 3/277 | 11/94 | 3/93 |
| HeadacheNervous system disorders | 21/277 | 1/94 | 2/93 |
| PruritusSkin and subcutaneous tissue disorders | 18/277 | 0/94 | 1/93 |
| Abnormal sensationGeneral disorders | 15/277 | 3/94 | 0/93 |
| Age Continuous(years) | Entire Study Population |
|---|---|
| Mean | 57.0 ± 17.5 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 168 |
| Male | 109 |
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