Post-surgical Dental Pain
Conditions
Keywords
dental pain, paracetamol, Post-surgical dental pain
Brief summary
GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. 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 18 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).
Interventions
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 to 45 years with moderate-to-severe dental pain as assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue (VAS) following the surgical removal of up to two mandibular third molars. If only one mandibular third molar is removed, it must be a full bony impaction. If two mandibular third molars are removed, both may be partial bony impactions OR there may be a combination of one full bony impaction with the second tooth being erupted, soft tissue impaction, or partial bony impaction. Ipsilateral maxillary third molars may be removed at the surgeon's discretion, regardless of impaction level.
Exclusion criteria
* Pregnant and lactating females * Allergy/intolerance to study materials or nitrous oxide or local anaesthetic used during surgery * Current or recurrent liver, kidney or cardiac disease, stomach ulcers, gastrointestinal bleeding, gastroesophageal reflux disease, bronchospasm, rhinitis, urticaria or asthma
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 recorded 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. |
| Percentage of Participants Who Took Rescue Medication at 2 Hours | Baseline to 2 hours post dose | Percentage of participants who received rescue medication at different time points post dose. |
| Percentage of Participants Who Took Rescue Medication at 6 Hours | Baseline to 6 hours post dose | Percentage of participants who received rescue medication at different time points post dose. |
| 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 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 Score (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 722 screened participants, 321 were considered to be screen failures. Remaining 401 were randomized to study treatments.
Participants by arm
| Arm | Count |
|---|---|
| Paracetamol Caplet 1000mg Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route. | 163 |
| Paracetamol Caplet 650 mg Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route. | 158 |
| Placebo Caplet Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route. | 80 |
| Total | 401 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Paracetamol Caplet 1000mg | Paracetamol Caplet 650 mg | Placebo Caplet | Total |
|---|---|---|---|---|
| Age, Continuous | 19.7 Years STANDARD_DEVIATION 2.26 | 20.4 Years STANDARD_DEVIATION 2.81 | 20.6 Years STANDARD_DEVIATION 2.76 | 20.2 Years STANDARD_DEVIATION 2.61 |
| Number of participants with pain severity score measured on a rating scale Moderate | 109 Participants | 106 Participants | 53 Participants | 268 Participants |
| Number of participants with pain severity score measured on a rating scale Severe | 54 Participants | 52 Participants | 27 Participants | 133 Participants |
| Sex: Female, Male Female | 102 Participants | 104 Participants | 56 Participants | 262 Participants |
| Sex: Female, Male Male | 61 Participants | 54 Participants | 24 Participants | 139 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 | 28 / 163 | 28 / 158 | 18 / 80 |
| serious Total, serious adverse events | 0 / 163 | 0 / 158 | 0 / 80 |
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
Population: Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Caplet 1000mg | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | 16.08 Score on a scale | Standard Deviation 10.68 |
| Paracetamol Caplet 650 mg | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | 12.42 Score on a scale | Standard Deviation 9.89 |
| Placebo Caplet | Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours) | 4.63 Score on a scale | Standard Deviation 8.82 |
Comparison: Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 650 mg caplet.p-value: 0.000995% CI: [1.53, 5.89]ANCOVA
Comparison: Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.p-value: <0.000195% CI: [8.66, 14]ANCOVA
Comparison: Null hypothesis considered no difference in SPRID\^6h between Paracetamol 650 mg caplet and placebo caplet.p-value: <0.000195% CI: [4.94, 10.31]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 1000mg | Participants Global Assessment to Response to Treatment (PGART) | 2.20 Score on a scale | Standard Deviation 1.13 |
| Paracetamol Caplet 650 mg | Participants Global Assessment to Response to Treatment (PGART) | 1.80 Score on a scale | Standard Deviation 1.18 |
| Placebo Caplet | Participants Global Assessment to Response to Treatment (PGART) | 0.80 Score on a scale | Standard Deviation 1.05 |
Secondary
Percentage of Participants Who Took Rescue Medication at 2 Hours
Percentage of participants who received rescue medication at different time points post dose.
Time frame: Baseline to 2 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 (NUMBER) |
|---|---|---|
| Paracetamol Caplet 1000mg | Percentage of Participants Who Took Rescue Medication at 2 Hours | 0.00 Percentage of participants |
| Paracetamol Caplet 650 mg | Percentage of Participants Who Took Rescue Medication at 2 Hours | 0.00 Percentage of participants |
| Placebo Caplet | Percentage of Participants Who Took Rescue Medication at 2 Hours | 1.30 Percentage of participants |
Secondary
Percentage of Participants Who Took Rescue Medication at 6 Hours
Percentage of participants who received rescue medication at different time points post dose.
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 (NUMBER) |
|---|---|---|
| Paracetamol Caplet 1000mg | Percentage of Participants Who Took Rescue Medication at 6 Hours | 44.20 Percentage of participants |
| Paracetamol Caplet 650 mg | Percentage of Participants Who Took Rescue Medication at 6 Hours | 51.90 Percentage of participants |
| Placebo Caplet | Percentage of Participants Who Took Rescue Medication at 6 Hours | 70.00 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 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 1000mg | SPID Scores at 4 Hours | 3.88 Score on a scale | Standard Deviation 3.06 |
| Paracetamol Caplet 650 mg | SPID Scores at 4 Hours | 2.81 Score on a scale | Standard Deviation 2.52 |
| Placebo Caplet | SPID Scores at 4 Hours | 0.20 Score on a scale | Standard Deviation 2.13 |
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 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 1000mg | SPID Scores at 6 Hours | 5.02 Score on a scale | Standard Deviation 4.63 |
| Paracetamol Caplet 650 mg | SPID Scores at 6 Hours | 3.59 Score on a scale | Standard Deviation 4.01 |
| Placebo Caplet | SPID Scores at 6 Hours | 0.34 Score on a scale | Standard Deviation 3.51 |
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: 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 1000mg | SPRID at 2 Hours | 6.49 Score on a scale | Standard Deviation 3.11 |
| Paracetamol Caplet 650 mg | SPRID at 2 Hours | 5.57 Score on a scale | Standard Deviation 2.94 |
| Placebo Caplet | SPRID at 2 Hours | 1.55 Score on a scale | Standard Deviation 2.45 |
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 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 1000mg | SPRID at 4 Hours | 12.09 Score on a scale | Standard Deviation 6.93 |
| Paracetamol Caplet 650 mg | SPRID at 4 Hours | 9.45 Score on a scale | Standard Deviation 6.19 |
| Placebo Caplet | SPRID at 4 Hours | 3.00 Score on a scale | Standard Deviation 5.27 |
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 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 1000mg | Sum of Pain Intensity Difference (SPID) Scores at 2 Hours | 2.17 Score on a scale | Standard Deviation 1.37 |
| Paracetamol Caplet 650 mg | Sum of Pain Intensity Difference (SPID) Scores at 2 Hours | 1.77 Score on a scale | Standard Deviation 1.2 |
| Placebo Caplet | Sum of Pain Intensity Difference (SPID) Scores at 2 Hours | 0.19 Score on a scale | Standard Deviation 1.03 |
Secondary
Time to Confirmed First Perceptible 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 1000mg | Time to Confirmed First Perceptible Relief | 54.72 minutes | Standard Deviation 104.911 |
| Paracetamol Caplet 650 mg | Time to Confirmed First Perceptible Relief | 69.67 minutes | Standard Deviation 120.501 |
| Placebo Caplet | Time to Confirmed First Perceptible Relief | 225.70 minutes | Standard Deviation 162.884 |
Secondary
Time to Onset of Meaningful Pain Relief
Participants recorded 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 1000mg | Time to Onset of Meaningful Pain Relief | 70.53 minutes | Standard Deviation 101.474 |
| Paracetamol Caplet 650 mg | Time to Onset of Meaningful Pain Relief | 88.16 minutes | Standard Deviation 115.955 |
| Placebo Caplet | Time to Onset of Meaningful Pain Relief | 247.14 minutes | Standard Deviation 143.028 |
Secondary
Time to Start Using Rescue Medication
Median time of use of rescue medication by participants.
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 1000mg | Time to Start Using Rescue Medication | 360.00 minutes |
| Paracetamol Caplet 650 mg | Time to Start Using Rescue Medication | 314.00 minutes |
| Placebo Caplet | Time to Start Using Rescue Medication | 131.00 minutes |
Secondary
Total Pain Relief Score (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 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 1000mg | Total Pain Relief Score (TOTPAR) at 2 Hours | 4.31 Score on a scale | Standard Deviation 1.88 |
| Paracetamol Caplet 650 mg | Total Pain Relief Score (TOTPAR) at 2 Hours | 3.80 Score on a scale | Standard Deviation 1.89 |
| Placebo Caplet | Total Pain Relief Score (TOTPAR) at 2 Hours | 1.36 Score on a scale | Standard Deviation 1.59 |
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 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 1000mg | TOTPAR at 4 Hours | 8.21 Score on a scale | Standard Deviation 4.1 |
| Paracetamol Caplet 650 mg | TOTPAR at 4 Hours | 6.64 Score on a scale | Standard Deviation 3.97 |
| Placebo Caplet | TOTPAR at 4 Hours | 2.79 Score on a scale | Standard Deviation 3.46 |
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 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 1000mg | TOTPAR at 6 Hours | 11.06 Score on a scale | Standard Deviation 6.41 |
| Paracetamol Caplet 650 mg | TOTPAR at 6 Hours | 8.83 Score on a scale | Standard Deviation 6.3 |
| Placebo Caplet | TOTPAR at 6 Hours | 4.29 Score on a scale | Standard Deviation 5.8 |