Trial Outcomes & Findings for Post-operative Dental Pain Study Comparing Analgesic Efficacy (NCT NCT01082081)
NCT ID: NCT01082081
Last Updated: 2015-05-13
Results Overview
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 \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
COMPLETED
PHASE4
300 participants
Every two hours from baseline to 6 hours post dose
2015-05-13
Participant Flow
Participants were recruited at the clinical site.
Of 438 screened participants, 138 were considered to be screen failures. Remaining 300 were randomized to study treatments.
Participant milestones
| Measure |
Paracetamol Caplet 1000 Milligrams (mg)
Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (total dose= 1000 mg), with 150 milliliter (mL) of water through oral route.
|
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.
|
Placebo Caplet
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Overall Study
STARTED
|
121
|
119
|
60
|
|
Overall Study
COMPLETED
|
121
|
118
|
58
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Paracetamol Caplet 1000 Milligrams (mg)
Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (total dose= 1000 mg), with 150 milliliter (mL) of water through oral route.
|
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.
|
Placebo Caplet
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Other Reason
|
0
|
1
|
0
|
Baseline Characteristics
Post-operative Dental Pain Study Comparing Analgesic Efficacy
Baseline characteristics by cohort
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.0 Years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
23.9 Years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
23.5 Years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
23.9 Years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Number of participants with pain severity score measured on a rating scale
Moderate
|
97 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Number of participants with pain severity score measured on a rating scale
Severe
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Every two hours from baseline to 6 hours post doseSPRID: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 \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
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
|
5.87 Units on a scale
Standard Deviation 9.03
|
3.35 Units on a scale
Standard Deviation 9.67
|
SECONDARY outcome
Timeframe: Baseline to 6 hours post dosePopulation: 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.
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.
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Time to Confirmed First Perceptible Pain Relief
|
80.63 minutes
Standard Deviation 132.65
|
119.10 minutes
Standard Deviation 156.44
|
189.53 minutes
Standard Deviation 172.28
|
SECONDARY outcome
Timeframe: Baseline to 6 hours post dosePopulation: 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.
Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Time to Onset of Meaningful Pain Relief
|
96.44 minutes
Standard Deviation 128.64
|
129.75 minutes
Standard Deviation 150.38
|
207.67 minutes
Standard Deviation 162.01
|
SECONDARY outcome
Timeframe: Baseline to 6 hours post dosePopulation: 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.
Median time of use of rescue medication by participants was calculated.
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Time to Start Using Rescue Medication
|
242.00 minutes
Interval 92.0 to 360.0
|
189.00 minutes
Interval 65.0 to 360.0
|
148.00 minutes
Interval 61.0 to 360.0
|
SECONDARY outcome
Timeframe: Baseline to 2 hours post dosePopulation: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
Percentage of participants who received rescue medication within 2 hours
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Percentage of Participants Who Took Rescue Medication Within 2 Hours
|
5.00 Percentage of participants
|
11.80 Percentage of participants
|
18.30 Percentage of participants
|
SECONDARY outcome
Timeframe: Within 2 to 6 hours post dosePopulation: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
Percentage of participants who took rescue medication during 2 to 6 hours
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours
|
57.9 Percentage of participants
|
55.5 Percentage of participants
|
53.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Every two hours from baseline to 2 hours post dosePopulation: ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
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 \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
SPRID at 2 Hours
|
4.62 Units on a scale
Standard Deviation 3.31
|
3.26 Units on a scale
Standard Deviation 2.98
|
1.49 Units on a scale
Standard Deviation 2.54
|
SECONDARY outcome
Timeframe: Every two hours from baseline to 4 hours post dosePopulation: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
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 \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
SPRID at 4 Hours
|
7.82 Units on a scale
Standard Deviation 7.36
|
4.42 Units on a scale
Standard Deviation 5.55
|
2.07 Units on a scale
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: Every two hours from baseline to 2 hours post dosePopulation: ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
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 \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Total Pain Relief (TOTPAR) at 2 Hours
|
3.33 Units on a scale
Standard Deviation 1.98
|
2.46 Units on a scale
Standard Deviation 1.81
|
1.47 Units on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Every two hours from baseline to 4 hours post dosePopulation: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
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 \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
TOTPAR at 4 Hours
|
5.82 Units on a scale
Standard Deviation 4.37
|
3.73 Units on a scale
Standard Deviation 3.32
|
2.55 Units on a scale
Standard Deviation 3.15
|
SECONDARY outcome
Timeframe: Every two hours from baseline to 6 hours post dosePopulation: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
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 \[0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief\].
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
TOTPAR at 6 Hours
|
8.05 Units on a scale
Standard Deviation 7.00
|
5.18 Units on a scale
Standard Deviation 5.44
|
4.10 Units on a scale
Standard Deviation 5.72
|
SECONDARY outcome
Timeframe: Every two hours from baseline to 2 hours post dosePopulation: ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Sum of Pain Intensity Difference (SPID) Scores at 2 Hours
|
1.3 Units on a scale
Standard Deviation 1.5
|
0.8 Units on a scale
Standard Deviation 1.3
|
0.0 Units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Every two hours from baseline to 4 hours post dosePopulation: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
SPID Scores at 4 Hours
|
2.0 Units on a scale
Standard Deviation 3.3
|
0.7 Units on a scale
Standard Deviation 2.6
|
-0.5 Units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Every two hours from baseline to 6 hours post dosePopulation: ITT population: All participants who received one study treatment and had at least one post-baseline efficacy assessment.
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.
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
SPID Scores at 6 Hours
|
2.6 Units on a scale
Standard Deviation 5.1
|
0.7 Units on a scale
Standard Deviation 4.1
|
-0.8 Units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline to 6 hours post dosePopulation: ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.
Outcome measures
| Measure |
Paracetamol Caplet 1000 mg
n=121 Participants
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 Participants
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 Participants
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Participants Global Assessment to Response to Treatment (PGART)
|
1.54 Units on a scale
Standard Deviation 1.20
|
1.24 Units on a scale
Standard Deviation 1.11
|
0.63 Units on a scale
Standard Deviation 0.92
|
Adverse Events
Paracetamol Caplet 1000 mg
Paracetamol Caplet 500 mg
Placebo Caplet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paracetamol Caplet 1000 mg
n=121 participants at risk
Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
|
Paracetamol Caplet 500 mg
n=119 participants at risk
Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
|
Placebo Caplet
n=60 participants at risk
Participants were administered with two placebo caplets, with 150 mL of water through oral route.
|
|---|---|---|---|
|
Infections and infestations
Alveolar Osteitis
|
16.5%
20/121 • Number of events 20 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
15.1%
18/119 • Number of events 18 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
5.0%
3/60 • Number of events 3 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Nervous system disorders
Headache
|
9.9%
12/121 • Number of events 13 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
5.9%
7/119 • Number of events 7 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
10.0%
6/60 • Number of events 6 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
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Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER