Post-surgical Dental Pain
Conditions
Keywords
paracetamol, dental pain, Post-surgical dental pain
Brief summary
GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 16 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).
Interventions
Paracetamol 1000 mg
Paracetamol 500 mg
DRUGPlacebo
Placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Subjects aged 18-45 years with moderate-to-severe dental pain assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue scale (VAS) following surgical removal of third molars, of which at least one has to be a mandibular partially bony or full bony impaction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | Every two hours from baseline to 6 hours post dose | SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Onset of Meaningful Pain Relief | Baseline to 6 hours post dose | Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief. |
| Time to Start Using Rescue Medication | Baseline to 6 hours post dose | Median time of use of rescue medication by participants was calculated. |
| Percentage of Participants Who Took Rescue Medication Within 2 Hours | Baseline to 2 hours post dose | Percentage of participants who received rescue medication within 2 hours |
| Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours | Within 2 to 6 hours post dose | Percentage of participants who took rescue medication during 2 to 6 hours |
| SPRID at 2 Hours | Every two hours from baseline to 2 hours post dose | SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\] |
| SPRID at 4 Hours | Every two hours from baseline to 4 hours post dose | SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\] |
| Time to Confirmed First Perceptible Pain Relief | Baseline to 6 hours post dose | Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief. |
| TOTPAR at 4 Hours | Every two hours from baseline to 4 hours post dose | TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\]. |
| TOTPAR at 6 Hours | Every two hours from baseline to 6 hours post dose | TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\]. |
| Sum of Pain Intensity Difference (SPID) Scores at 2 Hours | Every two hours from baseline to 2 hours post dose | SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline. |
| SPID Scores at 4 Hours | Every two hours from baseline to 4 hours post dose | SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline. |
| SPID Scores at 6 Hours | Every two hours from baseline to 6 hours post dose | SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline. |
| Participants Global Assessment to Response to Treatment (PGART) | Baseline to 6 hours post dose | PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent. |
| Total Pain Relief (TOTPAR) at 2 Hours | Every two hours from baseline to 2 hours post dose | TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\]. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
Of 438 screened participants, 138 were considered to be screen failures. Remaining 300 were randomized to study treatments.
Participants by arm
| Arm | Count |
|---|---|
| Paracetamol Caplet 1000 mg Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route. | 121 |
| Paracetamol Caplet 500 mg Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route. | 119 |
| Placebo Caplet Participants were administered with two placebo caplets, with 150 mL of water through oral route. | 60 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Other Reason | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Paracetamol Caplet 1000 mg | Paracetamol Caplet 500 mg | Placebo Caplet | Total |
|---|---|---|---|---|
| Age, Continuous | 24.0 Years STANDARD_DEVIATION 5 | 23.9 Years STANDARD_DEVIATION 3.9 | 23.5 Years STANDARD_DEVIATION 4.9 | 23.9 Years STANDARD_DEVIATION 4.5 |
| Number of participants with pain severity score measured on a rating scale Moderate | 97 Participants | 97 Participants | 48 Participants | 242 Participants |
| Number of participants with pain severity score measured on a rating scale Severe | 24 Participants | 22 Participants | 12 Participants | 58 Participants |
| Sex: Female, Male Female | 68 Participants | 73 Participants | 37 Participants | 178 Participants |
| Sex: Female, Male Male | 53 Participants | 46 Participants | 23 Participants | 122 Participants |
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 | 32 / 121 | 25 / 119 | 9 / 60 |
| serious Total, serious adverse events | 0 / 121 | 0 / 119 | 0 / 60 |
Outcome results
Primary
Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
Time frame: Every two hours from baseline to 6 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | 10.60 Units on a scale | Standard Deviation 11.75 |
| Paracetamol Caplet 500 mg | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | 5.87 Units on a scale | Standard Deviation 9.03 |
| Placebo Caplet | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | 3.35 Units on a scale | Standard Deviation 9.67 |
Comparison: Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 500 mg caplet.p-value: 0.000495% CI: [2.15, 7.39]ANCOVA
Comparison: Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.p-value: <0.000195% CI: [4.04, 10.45]ANCOVA
Comparison: Null hypothesis considered no difference in SPRID\^6h between Paracetamol 500 mg caplet and placebo caplet.p-value: 0.130795% CI: [-0.74, 5.69]ANCOVA
Secondary
Participants Global Assessment to Response to Treatment (PGART)
PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.
Time frame: Baseline to 6 hours post dose
Population: ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | Participants Global Assessment to Response to Treatment (PGART) | 1.54 Units on a scale | Standard Deviation 1.2 |
| Paracetamol Caplet 500 mg | Participants Global Assessment to Response to Treatment (PGART) | 1.24 Units on a scale | Standard Deviation 1.11 |
| Placebo Caplet | Participants Global Assessment to Response to Treatment (PGART) | 0.63 Units on a scale | Standard Deviation 0.92 |
Secondary
Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours
Percentage of participants who took rescue medication during 2 to 6 hours
Time frame: Within 2 to 6 hours post dose
Population: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paracetamol Caplet 1000 mg | Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours | 57.9 Percentage of participants |
| Paracetamol Caplet 500 mg | Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours | 55.5 Percentage of participants |
| Placebo Caplet | Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours | 53.3 Percentage of participants |
Secondary
Percentage of Participants Who Took Rescue Medication Within 2 Hours
Percentage of participants who received rescue medication within 2 hours
Time frame: Baseline to 2 hours post dose
Population: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paracetamol Caplet 1000 mg | Percentage of Participants Who Took Rescue Medication Within 2 Hours | 5.00 Percentage of participants |
| Paracetamol Caplet 500 mg | Percentage of Participants Who Took Rescue Medication Within 2 Hours | 11.80 Percentage of participants |
| Placebo Caplet | Percentage of Participants Who Took Rescue Medication Within 2 Hours | 18.30 Percentage of participants |
Secondary
SPID Scores at 4 Hours
SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Time frame: Every two hours from baseline to 4 hours post dose
Population: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | SPID Scores at 4 Hours | 2.0 Units on a scale | Standard Deviation 3.3 |
| Paracetamol Caplet 500 mg | SPID Scores at 4 Hours | 0.7 Units on a scale | Standard Deviation 2.6 |
| Placebo Caplet | SPID Scores at 4 Hours | -0.5 Units on a scale | Standard Deviation 2.6 |
Secondary
SPID Scores at 6 Hours
SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Time frame: Every two hours from baseline to 6 hours post dose
Population: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | SPID Scores at 6 Hours | 2.6 Units on a scale | Standard Deviation 5.1 |
| Paracetamol Caplet 500 mg | SPID Scores at 6 Hours | 0.7 Units on a scale | Standard Deviation 4.1 |
| Placebo Caplet | SPID Scores at 6 Hours | -0.8 Units on a scale | Standard Deviation 4.4 |
Secondary
SPRID at 2 Hours
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
Time frame: Every two hours from baseline to 2 hours post dose
Population: ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | SPRID at 2 Hours | 4.62 Units on a scale | Standard Deviation 3.31 |
| Paracetamol Caplet 500 mg | SPRID at 2 Hours | 3.26 Units on a scale | Standard Deviation 2.98 |
| Placebo Caplet | SPRID at 2 Hours | 1.49 Units on a scale | Standard Deviation 2.54 |
Secondary
SPRID at 4 Hours
SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
Time frame: Every two hours from baseline to 4 hours post dose
Population: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | SPRID at 4 Hours | 7.82 Units on a scale | Standard Deviation 7.36 |
| Paracetamol Caplet 500 mg | SPRID at 4 Hours | 4.42 Units on a scale | Standard Deviation 5.55 |
| Placebo Caplet | SPRID at 4 Hours | 2.07 Units on a scale | Standard Deviation 5.45 |
Secondary
Sum of Pain Intensity Difference (SPID) Scores at 2 Hours
SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (timet - timet-1) Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.
Time frame: Every two hours from baseline to 2 hours post dose
Population: ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | Sum of Pain Intensity Difference (SPID) Scores at 2 Hours | 1.3 Units on a scale | Standard Deviation 1.5 |
| Paracetamol Caplet 500 mg | Sum of Pain Intensity Difference (SPID) Scores at 2 Hours | 0.8 Units on a scale | Standard Deviation 1.3 |
| Placebo Caplet | Sum of Pain Intensity Difference (SPID) Scores at 2 Hours | 0.0 Units on a scale | Standard Deviation 1.2 |
Secondary
Time to Confirmed First Perceptible Pain Relief
Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
Time frame: Baseline to 6 hours post dose
Population: ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | Time to Confirmed First Perceptible Pain Relief | 80.63 minutes | Standard Deviation 132.65 |
| Paracetamol Caplet 500 mg | Time to Confirmed First Perceptible Pain Relief | 119.10 minutes | Standard Deviation 156.44 |
| Placebo Caplet | Time to Confirmed First Perceptible Pain Relief | 189.53 minutes | Standard Deviation 172.28 |
Secondary
Time to Onset of Meaningful Pain Relief
Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.
Time frame: Baseline to 6 hours post dose
Population: ITT population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored at the time 360 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | Time to Onset of Meaningful Pain Relief | 96.44 minutes | Standard Deviation 128.64 |
| Paracetamol Caplet 500 mg | Time to Onset of Meaningful Pain Relief | 129.75 minutes | Standard Deviation 150.38 |
| Placebo Caplet | Time to Onset of Meaningful Pain Relief | 207.67 minutes | Standard Deviation 162.01 |
Secondary
Time to Start Using Rescue Medication
Median time of use of rescue medication by participants was calculated.
Time frame: Baseline to 6 hours post dose
Population: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment. Participants who did not achieve first perceptible pain relief during the 6 hours of the study period or took rescue medication were censored.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Paracetamol Caplet 1000 mg | Time to Start Using Rescue Medication | 242.00 minutes |
| Paracetamol Caplet 500 mg | Time to Start Using Rescue Medication | 189.00 minutes |
| Placebo Caplet | Time to Start Using Rescue Medication | 148.00 minutes |
Secondary
Total Pain Relief (TOTPAR) at 2 Hours
TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Time frame: Every two hours from baseline to 2 hours post dose
Population: ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | Total Pain Relief (TOTPAR) at 2 Hours | 3.33 Units on a scale | Standard Deviation 1.98 |
| Paracetamol Caplet 500 mg | Total Pain Relief (TOTPAR) at 2 Hours | 2.46 Units on a scale | Standard Deviation 1.81 |
| Placebo Caplet | Total Pain Relief (TOTPAR) at 2 Hours | 1.47 Units on a scale | Standard Deviation 1.53 |
Secondary
TOTPAR at 4 Hours
TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Time frame: Every two hours from baseline to 4 hours post dose
Population: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | TOTPAR at 4 Hours | 5.82 Units on a scale | Standard Deviation 4.37 |
| Paracetamol Caplet 500 mg | TOTPAR at 4 Hours | 3.73 Units on a scale | Standard Deviation 3.32 |
| Placebo Caplet | TOTPAR at 4 Hours | 2.55 Units on a scale | Standard Deviation 3.15 |
Secondary
TOTPAR at 6 Hours
TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief. TOTPARt = ∑PR x (timet - timet-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Time frame: Every two hours from baseline to 6 hours post dose
Population: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000 mg | TOTPAR at 6 Hours | 8.05 Units on a scale | Standard Deviation 7 |
| Paracetamol Caplet 500 mg | TOTPAR at 6 Hours | 5.18 Units on a scale | Standard Deviation 5.44 |
| Placebo Caplet | TOTPAR at 6 Hours | 4.10 Units on a scale | Standard Deviation 5.72 |