A Phase 3 interventional study of Tramadol Hydrochloride and Acetaminophen in Pain and Postoperative Pain, sponsored by Janssen Pharmaceutical K.K.. Completed at 12 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2016-03-31.
Sponsored by Janssen Pharmaceutical K.K. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.
This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm [no pain] to 100 mm [worst possible pain]), following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts: Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. Participants' safety will be monitored throughout the study.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 328 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (\>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
Drug: Placebo · Drug: Tramadol plus Acetaminophen
Tramadol hydrochloride will be administered as single oral dosing of two capsules once at a dose of 75 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
Drug: Tramadol Hydrochloride · Drug: Placebo
Acetaminophen will be administered as single oral dosing of two capsules once at a dose of 650 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).
Drug: Acetaminophen · Drug: Placebo
Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).
Acetaminophen two oral capsules will be administered once as 650 mg.
Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.
Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively.
Also known as: JNS013
Total Pain Relief Based on Numerical Rating Scale (NRS) Score
Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.
Time frame: 8 hours
Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours
Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.
Time frame: Baseline up to 8 hours post-administration of study treatment
Sum of Pain Intensity Difference (SPID)
Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point \[8 hour\] score minus baseline \[0 hour\] score).
Time frame: Baseline up to 8 hours post-administration of study treatment
Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)
The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point \[8 hour\] score minus baseline \[0 hour\] score).
Time frame: Baseline up to 8 hours post-administration of study treatment
Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment
Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment
The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment
Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment
Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment
Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy
Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.
Time frame: Baseline up to 8 hours post-administration of study treatment
Percentage of Participants With Categorical Score for Patient Impressions
Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work.
Time frame: Baseline up to 8 hours post-administration of study treatment
Number of Participants Treated With a Relief Analgesic
Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.
Time frame: Baseline up to 8 hours post-administration of study treatment
Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain
Percentage of participants were assessed with treatment response based on "evaluation criteria for efficacy of analgesics in post-tooth-extraction pain" for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as "very effective, effective, somewhat effective and ineffective" for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as "extremely useful, useful, not useful \& could not be assessed" for overall evaluation (OE).
Time frame: Baseline up to 8 hours post-administration of study treatment
| Milestone | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| Started | 132 | 66 | 130 |
| Completed | 129 | 60 | 126 |
| Not completed | 3 | 6 | 4 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Worsening of the symptoms | 3 | 5 | 3 |
Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.
| Units on a scale | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| Total Pain Relief Based on Numerical Rating Scale (NRS) Score | 17.7 ± 7.91 | 12.4 ± 8.36 | 13.3 ± 8.07 |
Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response.
| Units on a scale | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| 0-4 hours | 9.6 ± 3.90 | 6.3 ± 4.11 | 7.4 ± 3.97 |
| 4-8 hours | 8.0 ± 4.73 | 6.1 ± 4.67 | 5.9 ± 4.71 |
Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point \[8 hour\] score minus baseline \[0 hour\] score).
| Units on a scale | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| Sum of Pain Intensity Difference (SPID) | 6.4 ± 5.90 | 2.9 ± 5.12 | 4.1 ± 5.84 |
The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point \[8 hour\] score minus baseline \[0 hour\] score).
| Units on a scale | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) | 24.0 ± 13.03 | 15.3 ± 12.43 | 17.4 ± 13.17 |
Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response.
| Units on a scale | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| Change at Hour 0.5 | -22.11 ± 23.466 | -4.28 ± 20.001 | -15.50 ± 22.336 |
| Change at Hour 1 | -36.79 ± 23.603 | -12.82 ± 27.372 | -26.68 ± 24.570 |
| Change at Hour 2 | -42.71 ± 23.631 | -20.94 ± 27.904 | -28.43 ± 27.583 |
| Change at Hour 3 | -41.40 ± 26.707 | -25.75 ± 28.509 | -28.40 ± 30.544 |
| Change at Hour 4 | -37.70 ± 27.266 | -21.75 ± 29.870 | -24.83 ± 30.753 |
| Change at Hour 5 | -34.78 ± 28.173 | -17.56 ± 29.110 | -21.48 ± 31.350 |
| Change at Hour 6 | -30.20 ± 30.932 | -15.70 ± 31.033 | -17.51 ± 31.875 |
| Change at Hour 7 | -26.37 ± 32.456 | -13.18 ± 30.335 | -15.62 ± 32.562 |
| Change at Hour 8 | -22.85 ± 33.116 | -13.03 ± 30.916 | -14.48 ± 32.638 |
The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.
| Units on a scale | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| PID:Change at Hour 0.5 | 0.6 ± 0.67 | 0.1 ± 0.55 | 0.5 ± 0.73 |
| PID:Change at Hour 1 | 0.9 ± 0.71 | 0.4 ± 0.70 | 0.7 ± 0.72 |
| PID:Change at Hour 2 | 1.1 ± 0.78 | 0.5 ± 0.71 | 0.8 ± 0.79 |
| PID:Change at Hour 3 | 1.1 ± 0.87 | 0.5 ± 0.73 | 0.7 ± 0.84 |
| PID:Change at Hour 4 | 0.9 ± 0.85 | 0.4 ± 0.70 | 0.6 ± 0.84 |
| PID:Change at Hour 5 | 0.8 ± 0.85 | 0.3 ± 0.73 | 0.5 ± 0.88 |
| PID:Change at Hour 6 | 0.7 ± 0.88 | 0.4 ± 0.80 | 0.4 ± 0.88 |
| PID:Change at Hour 7 | 0.6 ± 0.92 | 0.2 ± 0.77 | 0.3 ± 0.93 |
| PID:Change at Hour 8 | 0.5 ± 0.94 | 0.2 ± 0.77 | 0.3 ± 0.91 |
Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.
| Units on a scale | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| PAR:Change at Hour 0.5 | 1.5 ± 1.12 | 0.7 ± 0.86 | 1.3 ± 0.99 |
| PAR:Change at Hour 1 | 2.3 ± 1.08 | 1.4 ± 1.13 | 2.0 ± 1.11 |
| PAR:Change at Hour 2 | 2.7 ± 1.06 | 1.7 ± 1.23 | 2.0 ± 1.18 |
| PAR:Change at Hour 3 | 2.6 ± 1.18 | 1.9 ± 1.20 | 2.0 ± 1.21 |
| PAR:Change at Hour 4 | 2.4 ± 1.22 | 1.7 ± 1.18 | 1.8 ± 1.20 |
| PAR:Change at Hour 5 | 2.2 ± 1.21 | 1.6 ± 1.16 | 1.6 ± 1.27 |
| PAR:Change at Hour 6 | 2.1 ± 1.20 | 1.6 ± 1.28 | 1.5 ± 1.25 |
| PAR:Change at Hour 7 | 1.9 ± 1.30 | 1.5 ± 1.19 | 1.4 ± 1.27 |
| PAR:Change at Hour 8 | 1.8 ± 1.30 | 1.5 ± 1.15 | 1.4 ± 1.25 |
Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated.
| Units on a scale | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| PRID:Change at Hour 0.5 | 2.1 ± 1.67 | 0.8 ± 1.29 | 1.8 ± 1.61 |
| PRID:Change at Hour 1 | 3.2 ± 1.68 | 1.8 ± 1.71 | 2.7 ± 1.69 |
| PRID:Change at Hour 2 | 3.8 ± 1.71 | 2.2 ± 1.80 | 2.8 ± 1.85 |
| PRID:Change at Hour 3 | 3.7 ± 1.92 | 2.4 ± 1.75 | 2.7 ± 1.92 |
| PRID:Change at Hour 4 | 3.3 ± 1.95 | 2.1 ± 1.71 | 2.4 ± 1.92 |
| PRID:Change at Hour 5 | 3.0 ± 1.93 | 1.9 ± 1.74 | 2.1 ± 2.03 |
| PRID:Change at Hour 6 | 2.8 ± 1.96 | 1.9 ± 1.92 | 1.8 ± 2.00 |
| PRID:Change at Hour 7 | 2.5 ± 2.12 | 1.7 ± 1.81 | 1.8 ± 2.08 |
| PRID:Change at Hour 8 | 2.3 ± 2.12 | 1.7 ± 1.78 | 1.6 ± 2.04 |
Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment.
| Minutes | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| TOE (n=102, 36, 104) | 47.6 ± 40.88 | 82.8 ± 82.88 | 53.5 ± 47.97 |
| TOR (n=41, 14, 53) | 252.5 ± 119.03 | 207.9 ± 126.44 | 198.2 ± 120.24 |
Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work.
| Percentage of participants | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| Worked well | 28.7 ± 10 | 16.4 ± 12.43 | 15.7 ± 13.17 |
| Worked | 55.8 ± 6.29 | 44.3 ± 6.04 | 53.5 ± 6.39 |
| Worked a little | 13.2 ± 7.73 | 24.6 ± 7.04 | 22.8 ± 7.69 |
| Didn't work | 2.3 | 14.8 | 7.9 |
Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness.
| Participants | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| Number of Participants Treated With a Relief Analgesic | 37 | 25 | 54 |
Percentage of participants were assessed with treatment response based on "evaluation criteria for efficacy of analgesics in post-tooth-extraction pain" for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as "very effective, effective, somewhat effective and ineffective" for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as "extremely useful, useful, not useful \& could not be assessed" for overall evaluation (OE).
| Percentage of participants | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| PS:very effective (n=107, 46, 113) | 19.4 | 8.2 | 9.6 |
| PS:effective (n=107, 46, 113) | 2.8 | 0 | 0 |
| PS:somewhat effective (n=107, 46, 113) | 63.9 | 42.9 | 67.5 |
| PS:ineffective (n=107, 46, 113) | 13.9 | 49.0 | 22.8 |
| SPR:very effective (n=107, 46, 113) | 56.9 | 21.6 | 44.8 |
| SPR:effective (n=107, 46, 113) | 26.6 | 21.6 | 28.4 |
| SPR:somewhat effective (n=107, 46, 113) | 7.3 | 15.7 | 10.3 |
| SPR:ineffective (n=107, 46, 113) | 9.2 | 41.2 | 16.4 |
| DPR:very effective (n=41, 14, 53) | 39.0 | 28.6 | 24.5 |
| DPR:effective (n=41, 14, 53) | 26.8 | 35.7 | 28.3 |
| DPR:somewhat effective (n=41, 14, 53) | 17.1 | 7.1 | 20.8 |
| DPR:ineffective (n=41, 14, 53) | 17.1 | 28.6 | 26.4 |
| GE:very effective (n=107, 46, 113) | 2.8 | 0 | 0 |
| GE:effective (n=107, 46, 113) | 33.9 | 13.7 | 23.3 |
| GE:somewhat effective (n=107, 46, 113) | 46.8 | 31.4 | 53.4 |
| GE:ineffective (n=107, 46, 113) | 16.5 | 54.9 | 23.3 |
| OE:Extremely useful (n=107, 46, 113) | 0.9 | 0 | 0 |
| OE:useful (n=107, 46, 113) | 11.9 | 3.9 | 17.2 |
| OE:not useful (n=107, 46, 113) | 87.2 | 96.1 | 82.8 |
| OE:could not be assessed (n=107, 46, 113) | 0 | 0 | 0 |
Collected over Baseline up to Day 8. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | — | 0/132 (0%) | 82/132 (62.1%) |
| Tramadol Hydrochloride and Placebo | — | 0/66 (0%) | 40/66 (60.6%) |
| Acetaminophen and Placebo | — | 1/130 (0.8%) | 52/130 (40%) |
| Event | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| Drug hypersensitivityImmune system disorders | 0/132 | 0/66 | 1/130 |
| Event | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo |
|---|---|---|---|
| SomnolenceNervous system disorders | 39/132 | 15/66 | 14/130 |
| NauseaGastrointestinal disorders | 20/132 | 10/66 | 4/130 |
| DizzinessNervous system disorders | 12/132 | 5/66 | 0/130 |
| Blood bilirubin increasedInvestigations | 12/132 | 6/66 | 11/130 |
| Alveolar osteitisInfections and infestations | 6/132 | 1/66 | 10/130 |
| HeadacheNervous system disorders | 7/132 | 5/66 | 4/130 |
| VomitingGastrointestinal disorders | 10/132 | 2/66 | 1/130 |
| Feeling abnormalGeneral disorders | 4/132 | 5/66 | 1/130 |
| DiarrhoeaGastrointestinal disorders | 1/132 | 0/66 | 4/130 |
| Stomach discomfortGastrointestinal disorders | 4/132 | 0/66 | 0/130 |
| Age, Continuous(Years) | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo | Total |
|---|---|---|---|---|
| Mean | 28.1 ± 8.3 | 27.8 ± 8.6 | 27.5 ± 8.2 | 27.8 ± 8.3 |
| Sex: Female, Male(Participants) | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo | Total |
|---|---|---|---|---|
| Female | 61 | 32 | 66 | 159 |
| Male | 71 | 34 | 64 | 169 |
| Visual Analog Scale (VAS) Score(Units on a scale) | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo | Total |
|---|---|---|---|---|
| Mean | 62.28 ± 9.85 | 60.33 ± 7.63 | 61.32 ± 8.81 | 61.51 ± 9.04 |
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Janssen Pharmaceutical K.K.