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Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy

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ClinicalTrials.gov Identifier: NCT01075243
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Post-surgical Dental Pain
Interventions Drug: Paracetamol 1000 mg
Drug: Paracetamol 650 mg
Drug: Placebo
Enrollment 401
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.
Arm/Group Title Paracetamol Caplet 1000 Milligrams (mg) Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description 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. 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. Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Period Title: Overall Study
Started 163 158 80
Completed 157 155 80
Not Completed 6 3 0
Reason Not Completed
Lost to Follow-up             5             2             0
Withdrawal by Subject             1             1             0
Arm/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet Total
Hide Arm/Group Description 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. 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. Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route. Total of all reporting groups
Overall Number of Baseline Participants 163 158 80 401
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 158 participants 80 participants 401 participants
19.7  (2.26) 20.4  (2.81) 20.6  (2.76) 20.2  (2.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 158 participants 80 participants 401 participants
Female
102
  62.6%
104
  65.8%
56
  70.0%
262
  65.3%
Male
61
  37.4%
54
  34.2%
24
  30.0%
139
  34.7%
Number of participants with pain severity score measured on a rating scale   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 163 participants 158 participants 80 participants 401 participants
Moderate 109 106 53 268
Severe 54 52 27 133
[1]
Measure Description: 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.
1.Primary Outcome
Title Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population: All participants who received one study treatment and have at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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.
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
16.08  (10.68) 12.42  (9.89) 4.63  (8.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paracetamol Caplet 1000mg, Paracetamol Caplet 650 mg
Comments Null hypothesis considered no difference in SPRID^6h between Paracetamol 1000 mg caplet and Paracetamol 650 mg caplet.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 3.71
Confidence Interval (2-Sided) 95%
1.53 to 5.89
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Paracetamol Caplet 1000mg, Placebo Caplet
Comments Null hypothesis considered no difference in SPRID^6h between Paracetamol 1000 mg caplet and placebo caplet.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.
Method of Estimation Estimation Parameter Adjusted Mean DIfference
Estimated Value 11.33
Confidence Interval (2-Sided) 95%
8.66 to 14.00
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Paracetamol Caplet 650 mg, Placebo Caplet
Comments Null hypothesis considered no difference in SPRID^6h between Paracetamol 650 mg caplet and placebo caplet.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value 7.63
Confidence Interval 95%
4.94 to 10.31
Estimation Comments Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.
2.Secondary Outcome
Title Time to Confirmed First Perceptible Relief
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: minutes
54.72  (104.911) 69.67  (120.501) 225.70  (162.884)
3.Secondary Outcome
Title Time to Onset of Meaningful Pain Relief
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: minutes
70.53  (101.474) 88.16  (115.955) 247.14  (143.028)
4.Secondary Outcome
Title Time to Start Using Rescue Medication
Hide Description Median time of use of rescue medication by participants.
Time Frame Baseline to 6 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000 mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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.
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Median (Full Range)
Unit of Measure: minutes
360.00
(124.00 to 360.00)
314.00
(123.00 to 360.00)
131.00
(115.00 to 360.00)
5.Secondary Outcome
Title Percentage of Participants Who Took Rescue Medication at 2 Hours
Hide Description Percentage of participants who received rescue medication at different time points post dose.
Time Frame Baseline to 2 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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.
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Measure Type: Number
Unit of Measure: Percentage of participants
0.00 0.00 1.30
6.Secondary Outcome
Title Percentage of Participants Who Took Rescue Medication at 6 Hours
Hide Description Percentage of participants who received rescue medication at different time points post dose.
Time Frame Baseline to 6 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Measure Type: Number
Unit of Measure: Percentage of participants
44.20 51.90 70.00
7.Secondary Outcome
Title SPRID at 2 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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.
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
6.49  (3.11) 5.57  (2.94) 1.55  (2.45)
8.Secondary Outcome
Title SPRID at 4 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
12.09  (6.93) 9.45  (6.19) 3.00  (5.27)
9.Secondary Outcome
Title Total Pain Relief Score (TOTPAR) at 2 Hours
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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.
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
4.31  (1.88) 3.80  (1.89) 1.36  (1.59)
10.Secondary Outcome
Title TOTPAR at 4 Hours
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
8.21  (4.10) 6.64  (3.97) 2.79  (3.46)
11.Secondary Outcome
Title TOTPAR at 6 Hours
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
11.06  (6.41) 8.83  (6.30) 4.29  (5.80)
12.Secondary Outcome
Title Sum of Pain Intensity Difference (SPID) Scores at 2 Hours
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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.
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.17  (1.37) 1.77  (1.20) 0.19  (1.03)
13.Secondary Outcome
Title SPID Scores at 4 Hours
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
3.88  (3.06) 2.81  (2.52) 0.20  (2.13)
14.Secondary Outcome
Title SPID Scores at 6 Hours
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
5.02  (4.63) 3.59  (4.01) 0.34  (3.51)
15.Secondary Outcome
Title Participants Global Assessment to Response to Treatment (PGART)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All participants who received study treatment and had at least one post-baseline efficacy assessment.
Arm/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description:
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.
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.
Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
Overall Number of Participants Analyzed 163 158 80
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.20  (1.13) 1.80  (1.18) 0.80  (1.05)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Hide Arm/Group Description 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. 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. Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
All-Cause Mortality
Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/163 (0.00%)      0/158 (0.00%)      0/80 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paracetamol Caplet 1000mg Paracetamol Caplet 650 mg Placebo Caplet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/163 (17.18%)      28/158 (17.72%)      18/80 (22.50%)    
Gastrointestinal disorders       
Nausea  17/163 (10.43%)  18 17/158 (10.76%)  17 7/80 (8.75%)  8
Vomiting  7/163 (4.29%)  7 5/158 (3.16%)  5 4/80 (5.00%)  4
Nervous system disorders       
Headache  4/163 (2.45%)  4 6/158 (3.80%)  6 7/80 (8.75%)  7
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01075243    
Other Study ID Numbers: A4000685
First Submitted: February 23, 2010
First Posted: February 25, 2010
Results First Submitted: June 20, 2013
Results First Posted: April 29, 2015
Last Update Posted: April 29, 2015