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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol 1000mg | Experimental | Paracetamol 1000mg |
|
| Paracetamol 650 mg | Experimental | Paracetamol 650 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol 1000 mg | Drug | Paracetamol 1000mg |
| |
| Paracetamol 650 mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | Every two hours from Baseline to 6 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23972577 | Derived | Yue Y, Collaku A, Brown J, Buchanan WL, Reed K, Cooper SA, Otto J. Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. Clin Ther. 2013 Sep;35(9):1306-20. doi: 10.1016/j.clinthera.2013.07.422. Epub 2013 Aug 22. |
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Of 722 screened participants, 321 were considered to be screen failures. Remaining 401 were randomized to study treatments.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracetamol Caplet 1000 Milligrams (mg) | Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 milliliter (mL) of water through oral route. |
| FG001 | 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. |
| FG002 | Placebo Caplet | Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Paracetamol Caplet 650 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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] | Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from Baseline to 6 hours post dose |
All adverse events encountered or spontaneously reported following administration of any investigational product, or for up to 5 days after the last administration of investigational product were recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
Paracetamol 650 mg |
|
| Placebo | Drug | Placebo |
|
| 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. | Baseline to 6 hours post dose |
| Time to Start Using Rescue Medication | Median time of use of rescue medication by participants. | Baseline to 6 hours post dose |
| Percentage of Participants Who Took Rescue Medication at 2 Hours | Percentage of participants who received rescue medication at different time points post dose. | Baseline to 2 hours post dose |
| Percentage of Participants Who Took Rescue Medication at 6 Hours | Percentage of participants who received rescue medication at different time points post dose. | Baseline to 6 hours post dose |
| 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](streamdown:incomplete-link) | Every two hours from baseline to 2 hours post dose |
| 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](streamdown:incomplete-link) | Every two hours from baseline to 4 hours post dose |
| 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]. | Every two hours from baseline to 2 hours post dose |
| 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]. | Every two hours from baseline to 4 hours post dose |
| 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]. | Every two hours from baseline to 6 hours post dose |
| 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. | Every two hours from baseline to 2 hours post dose |
| 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. | Every two hours from baseline to 4 hours post dose |
| 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. | Every two hours from baseline to 6 hours post dose |
| 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. | Baseline to 6 hours post dose |
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. |
| BG002 | Placebo Caplet | Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of participants with pain severity score measured on a rating scale | Pain severity score was assessed on a 4-point categorical verbal rating scale. Total possible pain severity score range was no pain, mild pain, moderate and severe. | Number | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | Placebo Caplet | Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | minutes | Baseline to 6 hours post dose |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | minutes | Baseline to 6 hours post dose |
|
|
|
| Secondary | Time to Start Using Rescue Medication | Median time of use of rescue medication by participants. | 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. | Posted | Median | Full Range | minutes | Baseline to 6 hours post dose |
|
|
|
| Secondary | Percentage of Participants Who Took Rescue Medication at 2 Hours | Percentage of participants who received rescue medication at different time points post dose. | 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. | Posted | Number | Percentage of participants | Baseline to 2 hours post dose |
|
|
|
| Secondary | Percentage of Participants Who Took Rescue Medication at 6 Hours | Percentage of participants who received rescue medication at different time points post dose. | 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. | Posted | Number | Percentage of participants | Baseline to 6 hours post dose |
|
|
|
| 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](streamdown:incomplete-link) | 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. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from baseline to 2 hours post dose |
|
|
|
| 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](streamdown:incomplete-link) | 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. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from baseline to 4 hours post dose |
|
|
|
| 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]. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from baseline to 2 hours post dose |
|
|
|
| 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]. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from baseline to 4 hours post dose |
|
|
|
| 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]. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from baseline to 6 hours post dose |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from baseline to 2 hours post dose |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from baseline to 4 hours post dose |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Every two hours from baseline to 6 hours post dose |
|
|
|
| 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. | ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 6 hours post dose |
|
|
|
| 0 |
| 163 |
| 28 |
| 163 |
| EG001 | 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. | 0 | 158 | 28 | 158 |
| EG002 | Placebo Caplet | Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route. | 0 | 80 | 18 | 80 |
| Vomiting | Gastrointestinal disorders |
|
| Headache | Nervous system disorders |
|
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.
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |