Pain, Postoperative Pain
Conditions
Keywords
Pain, Tooth extraction, Oral surgery, Postoperative pain, JNS013, Tramadol hydrochloride, Acetaminophen
Brief summary
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.
Detailed description
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.
Interventions
DRUGAcetaminophen
Acetaminophen two oral capsules will be administered once as 650 mg.
DRUGPlacebo
Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen.
DRUGTramadol plus 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.
DRUGTramadol Hydrochloride
Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg).
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Participants planned to receive a tooth extraction of one mandibular impacted wisdom tooth * Participants who require bone removal and separation of the crown at tooth extraction * Participants whose intensity of pain associated with tooth extraction within 2 hours after tooth extraction is greater than or equal to 50.0 millimeter on the visual analog scale (VAS) * Participants who did not undergo general anesthesia or sedation at tooth extraction * Participants without an abnormality (including laboratory test values) corresponding to Grade 3 in the Criteria for severity classification of adverse drug reactions during the pretreatment observation period
Exclusion criteria
* Participants with conditions for which tramadol is contraindicated * Participants with conditions for which acetaminophen is contraindicated * Participants with history of convulsions or the possibility of convulsive seizures * Pregnant participants or those who may be pregnant, lactating mothers, and those who wish pregnancy during the study period * Participants with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Pain Relief Based on Numerical Rating Scale (NRS) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Difference (SPID) | Baseline up to 8 hours post-administration of study treatment | 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). |
| Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) | Baseline up to 8 hours post-administration of study treatment | 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). |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | Baseline up to 8 hours post-administration of study treatment | 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 to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | Baseline up to 8 hours post-administration of study treatment | 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. |
| Percentage of Participants With Categorical Score for Patient Impressions | Baseline up to 8 hours post-administration of study treatment | Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work. |
| Number of Participants Treated With a Relief Analgesic | Baseline up to 8 hours post-administration of study treatment | Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness. |
| Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | Baseline up to 8 hours post-administration of study treatment | 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). |
| 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 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo Tramadol hydrochloride and acetaminophen combination tablet was administered as 75 and 650 milligram respectively, as single oral dose of two tablets, 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). | 132 |
| Tramadol Hydrochloride and Placebo Tramadol hydrochloride was administered as 75 milligram, as single oral dose of two capsules, 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). | 66 |
| Acetaminophen and Placebo Acetaminophen was administered as 650 milligram as single oral dose of two capsules, 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). | 130 |
| Total | 328 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Worsening of the symptoms | 3 | 5 | 3 |
Baseline characteristics
| Characteristic | Tramadol Hydrochloride Plus Acetaminophen and Placebo | Tramadol Hydrochloride and Placebo | Acetaminophen and Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 28.1 Years STANDARD_DEVIATION 8.3 | 27.8 Years STANDARD_DEVIATION 8.6 | 27.5 Years STANDARD_DEVIATION 8.2 | 27.8 Years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 61 Participants | 32 Participants | 66 Participants | 159 Participants |
| Sex: Female, Male Male | 71 Participants | 34 Participants | 64 Participants | 169 Participants |
| Visual Analog Scale (VAS) Score | 62.28 Units on a scale STANDARD_DEVIATION 9.85 | 60.33 Units on a scale STANDARD_DEVIATION 7.63 | 61.32 Units on a scale STANDARD_DEVIATION 8.81 | 61.51 Units on a scale STANDARD_DEVIATION 9.04 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 82 / 132 | 40 / 66 | 52 / 130 |
| serious Total, serious adverse events | 0 / 132 | 0 / 66 | 1 / 130 |
Outcome results
Primary
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
Population: Final analysis set (FAS) population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score | 17.7 Units on a scale | Standard Deviation 7.91 |
| Tramadol Hydrochloride and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score | 12.4 Units on a scale | Standard Deviation 8.36 |
| Acetaminophen and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score | 13.3 Units on a scale | Standard Deviation 8.07 |
Comparison: Statistical Analysis 1 for Total pain relief based on numerical rating scale scorep-value: <0.0001Fisher Least Significant Difference Method
Comparison: Statistical Analysis 2 for Total pain relief based on numerical rating scale scorep-value: <0.0001Fisher Least Significant Difference Method
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 3 | -41.40 Units on a scale | Standard Deviation 26.707 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 8 | -22.85 Units on a scale | Standard Deviation 33.116 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 5 | -34.78 Units on a scale | Standard Deviation 28.173 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 4 | -37.70 Units on a scale | Standard Deviation 27.266 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 0.5 | -22.11 Units on a scale | Standard Deviation 23.466 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 7 | -26.37 Units on a scale | Standard Deviation 32.456 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 2 | -42.71 Units on a scale | Standard Deviation 23.631 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 1 | -36.79 Units on a scale | Standard Deviation 23.603 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | Change at Hour 6 | -30.20 Units on a scale | Standard Deviation 30.932 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 4 | -21.75 Units on a scale | Standard Deviation 29.87 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 0.5 | -4.28 Units on a scale | Standard Deviation 20.001 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 1 | -12.82 Units on a scale | Standard Deviation 27.372 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 2 | -20.94 Units on a scale | Standard Deviation 27.904 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 3 | -25.75 Units on a scale | Standard Deviation 28.509 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 5 | -17.56 Units on a scale | Standard Deviation 29.11 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 6 | -15.70 Units on a scale | Standard Deviation 31.033 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 7 | -13.18 Units on a scale | Standard Deviation 30.335 |
| Tramadol Hydrochloride and Placebo | 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 | Change at Hour 8 | -13.03 Units on a scale | Standard Deviation 30.916 |
| Acetaminophen and Placebo | 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 | Change at Hour 2 | -28.43 Units on a scale | Standard Deviation 27.583 |
| Acetaminophen and Placebo | 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 | Change at Hour 0.5 | -15.50 Units on a scale | Standard Deviation 22.336 |
| Acetaminophen and Placebo | 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 | Change at Hour 6 | -17.51 Units on a scale | Standard Deviation 31.875 |
| Acetaminophen and Placebo | 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 | Change at Hour 1 | -26.68 Units on a scale | Standard Deviation 24.57 |
| Acetaminophen and Placebo | 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 | Change at Hour 8 | -14.48 Units on a scale | Standard Deviation 32.638 |
| Acetaminophen and Placebo | 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 | Change at Hour 4 | -24.83 Units on a scale | Standard Deviation 30.753 |
| Acetaminophen and Placebo | 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 | Change at Hour 3 | -28.40 Units on a scale | Standard Deviation 30.544 |
| Acetaminophen and Placebo | 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 | Change at Hour 7 | -15.62 Units on a scale | Standard Deviation 32.562 |
| Acetaminophen and Placebo | 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 | Change at Hour 5 | -21.48 Units on a scale | Standard Deviation 31.35 |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 0.5 | 0.6 Units on a scale | Standard Deviation 0.67 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 1 | 0.9 Units on a scale | Standard Deviation 0.71 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 2 | 1.1 Units on a scale | Standard Deviation 0.78 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 3 | 1.1 Units on a scale | Standard Deviation 0.87 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 4 | 0.9 Units on a scale | Standard Deviation 0.85 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 5 | 0.8 Units on a scale | Standard Deviation 0.85 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 7 | 0.6 Units on a scale | Standard Deviation 0.92 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 8 | 0.5 Units on a scale | Standard Deviation 0.94 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PID:Change at Hour 6 | 0.7 Units on a scale | Standard Deviation 0.88 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 7 | 0.2 Units on a scale | Standard Deviation 0.77 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 3 | 0.5 Units on a scale | Standard Deviation 0.73 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 4 | 0.4 Units on a scale | Standard Deviation 0.7 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 5 | 0.3 Units on a scale | Standard Deviation 0.73 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 6 | 0.4 Units on a scale | Standard Deviation 0.8 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 0.5 | 0.1 Units on a scale | Standard Deviation 0.55 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 1 | 0.4 Units on a scale | Standard Deviation 0.7 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 8 | 0.2 Units on a scale | Standard Deviation 0.77 |
| Tramadol Hydrochloride and Placebo | 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 | PID:Change at Hour 2 | 0.5 Units on a scale | Standard Deviation 0.71 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 2 | 0.8 Units on a scale | Standard Deviation 0.79 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 1 | 0.7 Units on a scale | Standard Deviation 0.72 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 3 | 0.7 Units on a scale | Standard Deviation 0.84 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 7 | 0.3 Units on a scale | Standard Deviation 0.93 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 0.5 | 0.5 Units on a scale | Standard Deviation 0.73 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 4 | 0.6 Units on a scale | Standard Deviation 0.84 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 8 | 0.3 Units on a scale | Standard Deviation 0.91 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 6 | 0.4 Units on a scale | Standard Deviation 0.88 |
| Acetaminophen and Placebo | 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 | PID:Change at Hour 5 | 0.5 Units on a scale | Standard Deviation 0.88 |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 8 | 2.3 Units on a scale | Standard Deviation 2.12 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 6 | 2.8 Units on a scale | Standard Deviation 1.96 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 4 | 3.3 Units on a scale | Standard Deviation 1.95 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 0.5 | 2.1 Units on a scale | Standard Deviation 1.67 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 5 | 3.0 Units on a scale | Standard Deviation 1.93 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 2 | 3.8 Units on a scale | Standard Deviation 1.71 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 1 | 3.2 Units on a scale | Standard Deviation 1.68 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 7 | 2.5 Units on a scale | Standard Deviation 2.12 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PRID:Change at Hour 3 | 3.7 Units on a scale | Standard Deviation 1.92 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 0.5 | 0.8 Units on a scale | Standard Deviation 1.29 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 1 | 1.8 Units on a scale | Standard Deviation 1.71 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 2 | 2.2 Units on a scale | Standard Deviation 1.8 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 3 | 2.4 Units on a scale | Standard Deviation 1.75 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 4 | 2.1 Units on a scale | Standard Deviation 1.71 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 5 | 1.9 Units on a scale | Standard Deviation 1.74 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 6 | 1.9 Units on a scale | Standard Deviation 1.92 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 7 | 1.7 Units on a scale | Standard Deviation 1.81 |
| Tramadol Hydrochloride and Placebo | 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 | PRID:Change at Hour 8 | 1.7 Units on a scale | Standard Deviation 1.78 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 8 | 1.6 Units on a scale | Standard Deviation 2.04 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 6 | 1.8 Units on a scale | Standard Deviation 2 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 2 | 2.8 Units on a scale | Standard Deviation 1.85 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 1 | 2.7 Units on a scale | Standard Deviation 1.69 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 7 | 1.8 Units on a scale | Standard Deviation 2.08 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 4 | 2.4 Units on a scale | Standard Deviation 1.92 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 0.5 | 1.8 Units on a scale | Standard Deviation 1.61 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 5 | 2.1 Units on a scale | Standard Deviation 2.03 |
| Acetaminophen and Placebo | 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 | PRID:Change at Hour 3 | 2.7 Units on a scale | Standard Deviation 1.92 |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 3 | 2.6 Units on a scale | Standard Deviation 1.18 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 8 | 1.8 Units on a scale | Standard Deviation 1.3 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 5 | 2.2 Units on a scale | Standard Deviation 1.21 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 4 | 2.4 Units on a scale | Standard Deviation 1.22 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 0.5 | 1.5 Units on a scale | Standard Deviation 1.12 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 7 | 1.9 Units on a scale | Standard Deviation 1.3 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 2 | 2.7 Units on a scale | Standard Deviation 1.06 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 1 | 2.3 Units on a scale | Standard Deviation 1.08 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | 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 | PAR:Change at Hour 6 | 2.1 Units on a scale | Standard Deviation 1.2 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 4 | 1.7 Units on a scale | Standard Deviation 1.18 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 0.5 | 0.7 Units on a scale | Standard Deviation 0.86 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 1 | 1.4 Units on a scale | Standard Deviation 1.13 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 2 | 1.7 Units on a scale | Standard Deviation 1.23 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 3 | 1.9 Units on a scale | Standard Deviation 1.2 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 5 | 1.6 Units on a scale | Standard Deviation 1.16 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 6 | 1.6 Units on a scale | Standard Deviation 1.28 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 7 | 1.5 Units on a scale | Standard Deviation 1.19 |
| Tramadol Hydrochloride and Placebo | 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 | PAR:Change at Hour 8 | 1.5 Units on a scale | Standard Deviation 1.15 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 2 | 2.0 Units on a scale | Standard Deviation 1.18 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 0.5 | 1.3 Units on a scale | Standard Deviation 0.99 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 6 | 1.5 Units on a scale | Standard Deviation 1.25 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 1 | 2.0 Units on a scale | Standard Deviation 1.11 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 8 | 1.4 Units on a scale | Standard Deviation 1.25 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 4 | 1.8 Units on a scale | Standard Deviation 1.2 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 3 | 2.0 Units on a scale | Standard Deviation 1.21 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 7 | 1.4 Units on a scale | Standard Deviation 1.27 |
| Acetaminophen and Placebo | 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 | PAR:Change at Hour 5 | 1.6 Units on a scale | Standard Deviation 1.27 |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Number of Participants Treated With a Relief Analgesic | 37 Participants |
| Tramadol Hydrochloride and Placebo | Number of Participants Treated With a Relief Analgesic | 25 Participants |
| Acetaminophen and Placebo | Number of Participants Treated With a Relief Analgesic | 54 Participants |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked well | 28.7 Percentage of participants | 10 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked | 55.8 Percentage of participants | 6.29 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked a little | 13.2 Percentage of participants | 7.73 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Didn't work | 2.3 Percentage of participants | — |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Didn't work | 14.8 Percentage of participants | — |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked well | 16.4 Percentage of participants | 12.43 |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked a little | 24.6 Percentage of participants | 7.04 |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked | 44.3 Percentage of participants | 6.04 |
| Acetaminophen and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Didn't work | 7.9 Percentage of participants | — |
| Acetaminophen and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked | 53.5 Percentage of participants | 6.39 |
| Acetaminophen and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked a little | 22.8 Percentage of participants | 7.69 |
| Acetaminophen and Placebo | Percentage of Participants With Categorical Score for Patient Impressions | Worked well | 15.7 Percentage of participants | 13.17 |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:somewhat effective (n=107, 46, 113) | 46.8 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:ineffective (n=107, 46, 113) | 9.2 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:very effective (n=107, 46, 113) | 19.4 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:effective (n=107, 46, 113) | 33.9 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:very effective (n=41, 14, 53) | 39.0 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:ineffective (n=107, 46, 113) | 13.9 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:very effective (n=107, 46, 113) | 2.8 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:effective (n=41, 14, 53) | 26.8 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:could not be assessed (n=107, 46, 113) | 0 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:ineffective (n=41, 14, 53) | 17.1 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:somewhat effective (n=41, 14, 53) | 17.1 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:useful (n=107, 46, 113) | 11.9 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:very effective (n=107, 46, 113) | 56.9 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:not useful (n=107, 46, 113) | 87.2 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:Extremely useful (n=107, 46, 113) | 0.9 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:effective (n=107, 46, 113) | 26.6 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:somewhat effective (n=107, 46, 113) | 63.9 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:ineffective (n=107, 46, 113) | 16.5 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:somewhat effective (n=107, 46, 113) | 7.3 Percentage of participants |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:effective (n=107, 46, 113) | 2.8 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:useful (n=107, 46, 113) | 3.9 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:very effective (n=107, 46, 113) | 8.2 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:effective (n=107, 46, 113) | 0 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:somewhat effective (n=107, 46, 113) | 42.9 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:ineffective (n=107, 46, 113) | 49.0 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:very effective (n=107, 46, 113) | 21.6 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:effective (n=107, 46, 113) | 21.6 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:somewhat effective (n=107, 46, 113) | 15.7 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:ineffective (n=107, 46, 113) | 41.2 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:very effective (n=41, 14, 53) | 28.6 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:effective (n=41, 14, 53) | 35.7 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:somewhat effective (n=41, 14, 53) | 7.1 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:ineffective (n=41, 14, 53) | 28.6 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:very effective (n=107, 46, 113) | 0 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:effective (n=107, 46, 113) | 13.7 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:somewhat effective (n=107, 46, 113) | 31.4 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:ineffective (n=107, 46, 113) | 54.9 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:Extremely useful (n=107, 46, 113) | 0 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:not useful (n=107, 46, 113) | 96.1 Percentage of participants |
| Tramadol Hydrochloride and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:could not be assessed (n=107, 46, 113) | 0 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:effective (n=107, 46, 113) | 0 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:effective (n=107, 46, 113) | 23.3 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:somewhat effective (n=107, 46, 113) | 10.3 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:could not be assessed (n=107, 46, 113) | 0 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:somewhat effective (n=107, 46, 113) | 53.4 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:effective (n=107, 46, 113) | 28.4 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:not useful (n=107, 46, 113) | 82.8 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:ineffective (n=107, 46, 113) | 23.3 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:very effective (n=107, 46, 113) | 44.8 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:very effective (n=107, 46, 113) | 9.6 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:Extremely useful (n=107, 46, 113) | 0 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:ineffective (n=107, 46, 113) | 22.8 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:somewhat effective (n=41, 14, 53) | 20.8 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:effective (n=41, 14, 53) | 28.3 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | PS:somewhat effective (n=107, 46, 113) | 67.5 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:ineffective (n=41, 14, 53) | 26.4 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | DPR:very effective (n=41, 14, 53) | 24.5 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | OE:useful (n=107, 46, 113) | 17.2 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | GE:very effective (n=107, 46, 113) | 0 Percentage of participants |
| Acetaminophen and Placebo | Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain | SPR:ineffective (n=107, 46, 113) | 16.4 Percentage of participants |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Sum of Pain Intensity Difference (SPID) | 6.4 Units on a scale | Standard Deviation 5.9 |
| Tramadol Hydrochloride and Placebo | Sum of Pain Intensity Difference (SPID) | 2.9 Units on a scale | Standard Deviation 5.12 |
| Acetaminophen and Placebo | Sum of Pain Intensity Difference (SPID) | 4.1 Units on a scale | Standard Deviation 5.84 |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) | 24.0 Units on a scale | Standard Deviation 13.03 |
| Tramadol Hydrochloride and Placebo | Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) | 15.3 Units on a scale | Standard Deviation 12.43 |
| Acetaminophen and Placebo | Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) | 17.4 Units on a scale | Standard Deviation 13.17 |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure \& 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | TOE (n=102, 36, 104) | 47.6 Minutes | Standard Deviation 40.88 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | TOR (n=41, 14, 53) | 252.5 Minutes | Standard Deviation 119.03 |
| Tramadol Hydrochloride and Placebo | Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | TOE (n=102, 36, 104) | 82.8 Minutes | Standard Deviation 82.88 |
| Tramadol Hydrochloride and Placebo | Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | TOR (n=41, 14, 53) | 207.9 Minutes | Standard Deviation 126.44 |
| Acetaminophen and Placebo | Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | TOE (n=102, 36, 104) | 53.5 Minutes | Standard Deviation 47.97 |
| Acetaminophen and Placebo | Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy | TOR (n=41, 14, 53) | 198.2 Minutes | Standard Deviation 120.24 |
Secondary
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
Population: FAS population included all the participants who received the study treatment and had efficacy assessment data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | 0-4 hours | 9.6 Units on a scale | Standard Deviation 3.9 |
| Tramadol Hydrochloride Plus Acetaminophen and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | 4-8 hours | 8.0 Units on a scale | Standard Deviation 4.73 |
| Tramadol Hydrochloride and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | 0-4 hours | 6.3 Units on a scale | Standard Deviation 4.11 |
| Tramadol Hydrochloride and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | 4-8 hours | 6.1 Units on a scale | Standard Deviation 4.67 |
| Acetaminophen and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | 0-4 hours | 7.4 Units on a scale | Standard Deviation 3.97 |
| Acetaminophen and Placebo | Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours | 4-8 hours | 5.9 Units on a scale | Standard Deviation 4.71 |