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SB-705498 Dental Pain Study After Tooth Extraction

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ClinicalTrials.gov Identifier: NCT00281684
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition Toothache
Interventions Drug: SB705498 400 mg
Drug: SB705498 1000 mg
Drug: Placebo
Drug: Co-Codamol
Enrollment 145
Recruitment Details This study was conducted at 3 centers in the United Kingdom, 1 center in Korea, Republic of and 1 center in Italy from 07 December 2005 to 03 October 2007. A total of 145 participants were enrolled into the study.
Pre-assignment Details Participants already scheduled for 3rd molar tooth extraction, who were otherwise healthy, were recruited for this study. As soon as reasonably possible after completion of tooth extraction (but within 1 hour), participants were randomized to treatment and dosed with the study medication whilst local anesthetic was still active.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of SB705498 400 milligram (mg) capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol European Pharmacopoeia [Ph Eur] 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Period Title: Overall Study
Started 37 36 34 38
Completed 36 36 33 38
Not Completed 1 0 1 0
Reason Not Completed
Lost to Follow-up             0             0             1             0
Withdrawal by Subject             1             0             0             0
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol Total
Hide Arm/Group Description Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days. Total of all reporting groups
Overall Number of Baseline Participants 37 36 34 38 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 36 participants 34 participants 38 participants 145 participants
27.5  (7.37) 27.0  (6.45) 26.0  (7.26) 27.0  (6.36) 26.9  (6.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 34 participants 38 participants 145 participants
Female
19
  51.4%
18
  50.0%
20
  58.8%
19
  50.0%
76
  52.4%
Male
18
  48.6%
18
  50.0%
14
  41.2%
19
  50.0%
69
  47.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 36 participants 34 participants 38 participants 145 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
11
  29.7%
5
  13.9%
15
  44.1%
12
  31.6%
43
  29.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
1
   0.7%
Black or African American
1
   2.7%
1
   2.8%
1
   2.9%
2
   5.3%
5
   3.4%
White
25
  67.6%
29
  80.6%
18
  52.9%
23
  60.5%
95
  65.5%
More than one race
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
1
   0.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean of Pain Intensity Based on the Visual Analogue Scale (VAS)
Hide Description Pain intensity was assessed using VAS. These assessments were then summarized to give a weighted mean score. The VAS was a subjective assessment of post-operative pain intensity. The participants rated the pain intensity at the time of assessment by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left (0 mm) indicated no pain and extreme right (100 mm) indicated worst pain imaginable. This scale has no subscales. Only those participants available at the specified time points were analyzed.
Time Frame Up to 10 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population which comprised of all participants randomized to treatment, who took the study medication and who had at least one post-dose assessment. The ITT population did not include participants who took rescue medication or withdrew within the first 120 minutes after administration of study medication.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 35 34 32 36
Least Squares Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
37.45  (22.474) 34.95  (26.076) 38.84  (22.869) 17.15  (26.094)
2.Secondary Outcome
Title Change From Baseline in the Pain Intensity Based on the Verbal Rating Scale (VRS) up to 10 Hours Post Baseline
Hide Description Pain intensity was assessed using VRS. Participants also used a 4-point categorical VRS for the subjective assessment of postoperative pain. The score and it corresponding intensity was such that 0= no pain, 1= mild, 2= moderate and 3= severe. The VRS was collected as an independent measure of the participant’s pain and was not prospectively correlated to the study participant’s numerical score (number of millimeters) on the VAS. Participants were provided with a worksheet with a list of adjectives to read and they were asked to select the word by checking the box that best described their level of pain. The number associated with the adjective chosen by the participant constituted the pain intensity. Baseline (Day 1) value was the value obtained immediately prior to administration of study drug. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Up to 10 hours post Baseline (Day 1)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 34 33 38
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Pre-dose Number Analyzed 35 participants 34 participants 32 participants 36 participants
0.0  (0.00) 0.0  (0.00) 0.0  (0.00) 0.0  (0.00)
1 hour post-randomization Number Analyzed 35 participants 34 participants 32 participants 36 participants
0.3  (0.51) 0.3  (0.80) 0.6  (0.62) 0.3  (0.51)
2 hour post-randomization Number Analyzed 35 participants 34 participants 32 participants 36 participants
1.3  (0.89) 1.1  (1.05) 1.3  (0.90) 0.9  (0.87)
3 hour post-randomization Number Analyzed 23 participants 18 participants 17 participants 29 participants
1.3  (0.75) 1.0  (0.91) 1.4  (0.79) 1.0  (1.07)
4 hour post-randomization Number Analyzed 18 participants 15 participants 13 participants 25 participants
1.3  (0.77) 1.1  (1.03) 1.2  (0.90) 1.0  (1.06)
5 hour post-randomization Number Analyzed 16 participants 11 participants 11 participants 22 participants
1.2  (0.83) 0.9  (0.83) 0.8  (0.60) 1.1  (0.99)
6 hour post-randomization Number Analyzed 13 participants 11 participants 9 participants 17 participants
1.1  (0.76) 1.0  (0.89) 0.9  (0.60) 1.0  (1.06)
7 hour post-randomization Number Analyzed 12 participants 11 participants 8 participants 15 participants
1.2  (0.83) 1.1  (0.83) 0.9  (0.64) 0.8  (1.08)
8 hour post-randomization Number Analyzed 12 participants 10 participants 8 participants 13 participants
1.0  (0.74) 0.9  (0.88) 0.8  (0.71) 0.8  (1.28)
9 hour post-randomization Number Analyzed 11 participants 8 participants 8 participants 12 participants
1.0  (0.77) 0.6  (0.74) 0.8  (0.71) 0.7  (1.23)
10 hour post-randomization Number Analyzed 11 participants 8 participants 7 participants 10 participants
1.1  (0.83) 0.8  (1.04) 0.6  (0.53) 0.5  (1.18)
3.Secondary Outcome
Title Change From Baseline in the Pain Intensity Based on the VAS up to 10 Hours Post-Baseline
Hide Description Pain intensity was assessed using VAS. The VAS was a subjective assessment of post-operative pain intensity. The participants rated the pain intensity at the time of the assessment by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left (0 mm) indicated no pain and extreme right (100 mm) indicated worst pain imaginable. This scale has no subscales. The Baseline (Day 1) value was the value obtained immediately prior to administration of study drug. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) to 10 hours post Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 34 33 38
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
1 hour post randomization Number Analyzed 35 participants 34 participants 32 participants 36 participants
4.7  (9.12) 8.0  (17.66) 10.0  (16.55) 4.6  (9.40)
2 hour post randomization Number Analyzed 35 participants 34 participants 32 participants 36 participants
27.8  (22.02) 26.9  (30.74) 34.6  (24.72) 15.2  (25.76)
3 hour post randomization Number Analyzed 23 participants 18 participants 17 participants 29 participants
27.1  (17.10) 13.7  (18.96) 39.0  (25.52) 15.7  (26.09)
4 hour post randomization Number Analyzed 18 participants 15 participants 13 participants 25 participants
29.6  (20.16) 18.6  (23.22) 36.4  (26.07) 16.8  (25.08)
5 hour post randomization Number Analyzed 16 participants 11 participants 11 participants 22 participants
25.8  (18.98) 11.5  (23.56) 25.8  (20.96) 14.3  (21.50)
6 hour post randomization Number Analyzed 13 participants 11 participants 9 participants 17 participants
25.9  (19.00) 13.8  (24.91) 28.3  (21.19) 10.5  (26.51)
7 hour post randomization Number Analyzed 12 participants 11 participants 8 participants 15 participants
25.9  (21.55) 15.7  (24.64) 25.6  (19.65) 8.0  (28.17)
8 hour post randomization Number Analyzed 12 participants 10 participants 8 participants 13 participants
19.5  (18.59) 12.2  (25.28) 24.0  (18.88) 6.5  (28.92)
9 hour post randomization Number Analyzed 11 participants 8 participants 8 participants 12 participants
17.0  (16.94) 6.6  (19.81) 19.6  (15.03) 10.3  (32.63)
10 hour post randomization Number Analyzed 11 participants 8 participants 7 participants 10 participants
17.1  (20.52) 7.3  (20.27) 17.0  (15.47) 7.2  (25.19)
4.Secondary Outcome
Title Elapsed Time From Study Drug Administration to Rescue Analgesic Request
Hide Description Duration of Analgesic Effect (Time to First Rescue medication from study drug administration) is presented. Ibuprofen 400 mg was provided as rescue medication to be taken as required. The time when the rescue medication was administered was recorded on the case report form.
Time Frame Within 24 hours of administration of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 34 33 38
Median (Full Range)
Unit of Measure: Hours
5.13
(2.08 to 10.33)
4.27
(2.02 to 19.70)
3.12
(2.12 to 11.08)
6.88
(2.28 to 11.92)
5.Secondary Outcome
Title Number of Participants With Different Global Evaluation or Overall Impression of Study Medication Use and at 10 and 24 Hours Post Randomization
Hide Description Participants subjectively assessed their overall impression (global evaluation) of the study medication using a 4-point categorical scale, where 1= poor, 2= fair, 3= good and 4= excellent. Participants were provided with a list of adjectives and were asked to select the word by checking the box that best rated the study medication that they received for pain relief. The number associated with the adjective chosen by the participant constituted the global evaluation score. The study coordinator or designee transcribed the number corresponding to the selected adjective onto the case report form. The Global Evaluation was completed prior to receiving the first rescue medication, at 10 hours post-dose and prior to discharge from the unit.
Time Frame Prior to first rescue medication use and at 10 and 24 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 34 33 38
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-rescue: Poor
9
  24.3%
7
  20.6%
10
  30.3%
8
  21.1%
Pre-rescue: Fair
9
  24.3%
10
  29.4%
6
  18.2%
9
  23.7%
Pre-rescue: Good
8
  21.6%
6
  17.6%
6
  18.2%
12
  31.6%
Pre-rescue: Excellent
0
   0.0%
1
   2.9%
0
   0.0%
2
   5.3%
At 10 hour post-randomization: Poor
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
At 10 hour post-randomization: Fair
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
At 10 hour post-randomization: Good
0
   0.0%
0
   0.0%
1
   3.0%
0
   0.0%
At 10 hour post-randomization: Excellent
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
At 24 hour post-randomization: Poor
11
  29.7%
9
  26.5%
14
  42.4%
9
  23.7%
At 24 hour post-randomization: Fair
10
  27.0%
9
  26.5%
6
  18.2%
11
  28.9%
At 24 hour post-randomization: Good
9
  24.3%
12
  35.3%
9
  27.3%
13
  34.2%
At 24 hour post-randomization: Excellent
3
   8.1%
4
  11.8%
3
   9.1%
3
   7.9%
6.Secondary Outcome
Title VAS Mean Pain Scores From the Time of Rescue Medication up to 10 Hours Post Randomization
Hide Description Pain intensity was assessed using VAS. VAS was a subjective assessment of post-operative pain intensity. Participants rated the pain intensity at the time of assessment by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on extreme left, i.e., 0 mm indicated no pain and extreme right that is 100 mm indicated worst pain imaginable. This scale has no subscales.
Time Frame From the time of rescue medication to 10 hours post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants who used rescue medication were analyzed.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 34 33 38
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
3 hour post-randomization Number Analyzed 12 participants 16 participants 16 participants 7 participants
74.7  (18.68) 70.1  (17.87) 61.7  (26.50) 70.9  (22.57)
4 hour post-randomization Number Analyzed 17 participants 19 participants 20 participants 11 participants
69.4  (19.14) 64.9  (22.12) 59.2  (26.64) 65.5  (26.05)
5 hour post-randomization Number Analyzed 19 participants 23 participants 22 participants 14 participants
66.4  (20.25) 61.9  (21.83) 59.8  (26.53) 63.5  (27.58)
6 hour post-randomization Number Analyzed 21 participants 23 participants 24 participants 19 participants
63.9  (20.79) 61.9  (21.83) 59.3  (25.65) 56.2  (27.23)
7 hour post-randomization Number Analyzed 22 participants 23 participants 25 participants 21 participants
64.9  (20.83) 61.9  (21.83) 60.4  (25.67) 55.1  (26.03)
8 hour post-randomization Number Analyzed 22 participants 24 participants 25 participants 24 participants
64.9  (20.83) 61.5  (21.43) 60.4  (25.67) 55.8  (24.56)
9 hour post-randomization Number Analyzed 23 participants 26 participants 24 participants 25 participants
65.7  (20.70) 59.9  (21.31) 60.6  (26.20) 55.0  (24.40)
10 hour post-randomization Number Analyzed 23 participants 26 participants 26 participants 27 participants
65.7  (20.70) 59.9  (21.31) 59.9  (25.29) 53.7  (24.29)
7.Secondary Outcome
Title Number of Participants Requiring Rescue Medication Over Time
Hide Description Ibuprofen 400 mg was provided as rescue medication to be taken as required. The time that rescue medication was administered was recorded on the case report form. Number of participants requiring rescue medication up to 10 hour post-dose are presented.
Time Frame Up to 10 hour post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 34 33 38
Measure Type: Count of Participants
Unit of Measure: Participants
1 hour post-dose
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2 hour post-dose
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3 hour post-dose
12
  32.4%
16
  47.1%
16
  48.5%
7
  18.4%
4 hour post-dose
17
  45.9%
19
  55.9%
20
  60.6%
11
  28.9%
5 hour post-dose
19
  51.4%
23
  67.6%
22
  66.7%
14
  36.8%
6 hour post-dose
21
  56.8%
23
  67.6%
24
  72.7%
19
  50.0%
7 hour post-dose
22
  59.5%
23
  67.6%
25
  75.8%
21
  55.3%
8 hour post-dose
22
  59.5%
24
  70.6%
25
  75.8%
24
  63.2%
9 hour post-dose
23
  62.2%
26
  76.5%
24
  72.7%
25
  65.8%
10 hour post-dose
23
  62.2%
26
  76.5%
26
  78.8%
27
  71.1%
8.Secondary Outcome
Title Number of Participants From First Rescue Medication Use to Second Rescue Analgesic Request
Hide Description Ibuprofen 400 mg was provided as rescue medication to be taken as required. The time that rescue medication was administered was recorded on the case report form. Number of participants using the second rescue medication from the time the first rescue medication was used are presented.
Time Frame From first dose of rescue medication to second dose of rescue medication
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 34 33 38
Measure Type: Count of Participants
Unit of Measure: Participants
6
  16.2%
5
  14.7%
10
  30.3%
9
  23.7%
9.Secondary Outcome
Title Number of Participants With Adverse Events (AE) Over Time
Hide Description AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.
Time Frame Up to Follow-up (28 days)
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Hide Analysis Population Description
The Safety population which comprised of all participants who were randomized and took at least one capsule of study medication.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 36 34 38
Measure Type: Count of Participants
Unit of Measure: Participants
16
  43.2%
10
  27.8%
14
  41.2%
14
  36.8%
10.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Hide Description ECGs were recorded with the participant lying supine, having rested in this position for at least 5 minutes before each recording. Full 12 lead ECGs were recorded using an ECG device that automatically calculated the heart rate and measured PR, QRS, RR, QT and QT, QT corrected by Bazett's formula (QTcB) and QT corrected by Fridericia's formula (QTcF) intervals. Paper ECG traces were recorded at a standard paper speed of 25 millimeter/second and gain of 1mVolt/10 millimeter, using 2.5x4 format with lead II rhythm strip. Cardiac intervals were checked by a physician and then transcribed into the case report form. Number of participants with abnormal (not clinically significant [NCS] and clinically significant [CS]) ECG findings are presented.
Time Frame 28 days
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Hide Analysis Population Description
Safety population.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 36 34 38
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-dose, Abnormal-NCS
9
  24.3%
7
  19.4%
14
  41.2%
10
  26.3%
Pre-dose, Abnormal-CS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2 hour post-dose, Abnormal-NCS
16
  43.2%
10
  27.8%
15
  44.1%
7
  18.4%
2 hour post-dose, Abnormal-CS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4 hour post-dose, Abnormal-NCS
8
  21.6%
9
  25.0%
15
  44.1%
7
  18.4%
4 hour post-dose, Abnormal-CS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6 hour post-dose, Abnormal-NCS
4
  10.8%
9
  25.0%
8
  23.5%
9
  23.7%
6 hour post-dose, Abnormal-CS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8 hour post-dose, Abnormal-NCS
7
  18.9%
9
  25.0%
11
  32.4%
6
  15.8%
8 hour post-dose, Abnormal-CS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10 hour post-dose, Abnormal-NCS
8
  21.6%
11
  30.6%
13
  38.2%
8
  21.1%
10 hour post-dose, Abnormal-CS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
24 hour post-dose, Abnormal-NCS
7
  18.9%
12
  33.3%
10
  29.4%
8
  21.1%
24 hour post-dose, Abnormal-CS
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Second Degree Atrioventricular Block Over 24 Hours by Holter Tape
Hide Description Continuous ambulatory Holter ECG monitoring was performed for a 24-hour period at screening (Day -14 to Day -1) and from pre-dose (post surgery) to approximately 20 hours post-randomization. Number of participants with second degree atrioventricular block over 24 hours by Holter tape are presented.
Time Frame Up to 24 hours post-dose
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Hide Analysis Population Description
Safety population.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 36 34 38
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   2.9%
1
   2.6%
12.Secondary Outcome
Title Change From Baseline for Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Hide Description Supine SBP and DBP measurements were performed with the participant in a supine position after the participant has rested for at least 5 minutes. Assessment was completed pre-dose and then at 2, 4, 6, 8, 10 and discharge (approximately 24 hour) post randomization. Baseline (Day 1) value was the value obtained immediately prior to administration of study drug. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) to 24 hours post Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 36 34 38
Mean (Standard Deviation)
Unit of Measure: Millimeters of mercury (mmHg)
DBP: 2 hour post-randomization Number Analyzed 37 participants 36 participants 34 participants 38 participants
7.62  (8.388) 5.94  (9.411) 5.62  (7.758) 2.84  (8.952)
DBP: 4 hour post-randomization Number Analyzed 37 participants 36 participants 33 participants 38 participants
3.11  (7.770) 2.36  (7.772) 4.06  (8.489) 2.16  (8.106)
DBP: 6 hour post-randomization Number Analyzed 36 participants 36 participants 34 participants 38 participants
4.03  (7.129) -0.33  (8.384) -2.18  (6.930) 2.50  (7.783)
DBP: 8 hour post-randomization Number Analyzed 36 participants 36 participants 34 participants 38 participants
1.44  (6.631) 1.25  (8.005) -1.50  (7.712) -0.08  (7.691)
DBP: 10 hour post-randomization Number Analyzed 36 participants 36 participants 34 participants 38 participants
0.67  (6.612) -0.25  (6.971) -0.91  (6.824) -0.87  (8.217)
DBP: 24 hour post-randomization Number Analyzed 36 participants 36 participants 34 participants 38 participants
-0.61  (6.677) -1.97  (7.113) -1.74  (6.426) -2.32  (7.956)
SBP: 2 hour post-randomization Number Analyzed 37 participants 36 participants 34 participants 38 participants
8.08  (10.087) 5.25  (9.488) 7.18  (10.641) 2.39  (10.640)
SBP: 4 hour post-randomization Number Analyzed 37 participants 36 participants 33 participants 38 participants
5.08  (10.133) 3.97  (9.782) 7.09  (11.145) 4.42  (11.377)
SBP: 6 hour post-randomization Number Analyzed 36 participants 36 participants 34 participants 38 participants
5.06  (10.656) 0.11  (10.717) 1.21  (9.380) 2.84  (9.474)
SBP: 8 hour post-randomization Number Analyzed 36 participants 36 participants 34 participants 38 participants
2.08  (9.533) 1.28  (10.859) -0.65  (7.908) 0.08  (8.556)
SBP: 10 hour post-randomization Number Analyzed 36 participants 36 participants 34 participants 38 participants
2.31  (11.887) -0.44  (8.433) 1.06  (9.335) 2.18  (8.693)
SBP: 24 hour post-randomization Number Analyzed 36 participants 36 participants 34 participants 38 participants
0.58  (8.897) -1.03  (9.238) -0.32  (8.138) -0.13  (8.777)
13.Secondary Outcome
Title Change From Baseline for Vital Signs-Body Temperature
Hide Description Tympanic temperature was assessed at screening, pre-dose and then at 2, 4, 6, 8, 10 and discharge (approximately 24 hours) post-Baseline. Temperature was also recorded at the follow-up visit. The Baseline (Day 1) value was the value obtained immediately prior to administration of study drug. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.
Time Frame Baseline (Day 1) to 24 hours post Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 36 34 38
Mean (Standard Deviation)
Unit of Measure: Degree Celsius
2 hour post randomization Number Analyzed 21 participants 14 participants 34 participants 23 participants
0.17  (0.345) 0.28  (0.635) 0.47  (0.399) 0.07  (0.446)
4 hour post randomization Number Analyzed 21 participants 14 participants 33 participants 23 participants
0.27  (0.402) 0.49  (0.604) 0.74  (0.446) 0.24  (0.404)
6 hour post randomization Number Analyzed 20 participants 14 participants 34 participants 23 participants
0.47  (0.423) 0.59  (0.708) 0.75  (0.481) 0.41  (0.487)
8 hour post randomization Number Analyzed 21 participants 14 participants 34 participants 23 participants
0.50  (0.525) 0.33  (0.699) 0.67  (0.546) 0.45  (0.654)
10 hour post randomization Number Analyzed 21 participants 14 participants 34 participants 23 participants
0.43  (0.569) 0.28  (0.598) 0.46  (0.532) 0.32  (0.625)
24 hour post randomization Number Analyzed 20 participants 14 participants 34 participants 23 participants
0.26  (0.421) 0.37  (0.809) 0.45  (0.618) 0.34  (0.624)
14.Secondary Outcome
Title Number of Participants With Clinical Chemistry/ Hematology Values/ Serum Hormones Values of Potential Clinical Concern
Hide Description Hematology parameters included hemoglobin, packed cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, red blood cell count, white blood cell (WBC) count, platelets and differential WBC count. Clinical chemistry parameters included sodium, potassium, urea, creatinine, total protein, albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase (GGT), lactate dehydrogenase, calcium, magnesium, phosphate, cholesterol, high density lipoprotein cholesterol, triglycerides, glucose and creatinine kinase. Only those parameters for which at least one value of potential clinical concern was reported are presented.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 36 34 38
Measure Type: Count of Participants
Unit of Measure: Participants
Alkaline Phosphatase, High at Follow-up
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
Alanine Amino Transferase, High at screening
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
Alanine Amino Transferase, High at Follow-up
0
   0.0%
1
   2.8%
1
   2.9%
0
   0.0%
Total Bilirubin, High at screening
2
   5.4%
1
   2.8%
0
   0.0%
6
  15.8%
Total Bilirubin, High at 24 hour post-dose
5
  13.5%
3
   8.3%
6
  17.6%
8
  21.1%
Total Bilirubin, High at Follow-up
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium, Low at Follow-up
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
Creatine Kinase, High at screening
2
   5.4%
1
   2.8%
2
   5.9%
5
  13.2%
Creatine Kinase, High at 24 hour post-dose
0
   0.0%
0
   0.0%
1
   2.9%
1
   2.6%
Creatine Kinase, High at Follow-up
0
   0.0%
1
   2.8%
1
   2.9%
2
   5.3%
GGT, High at screening
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
GGT, High at 24 hour post-dose
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.3%
GGT, High at Follow-up
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.3%
Glucose, High at 24 hour post-dose
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose, High at Follow-up
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
Glucose, Low at Follow-up
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, Low at Follow-up
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium, High at screening
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
Potassium, High at 24 hour post-dose
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
Sodium, Low at Follow-up
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
WBC count, High at 24 hour post-dose
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.3%
15.Secondary Outcome
Title Number of Participants With Abnormal Urine Parameters
Hide Description Urinalysis parameters included protein, glucose, ketones, bilirubin, blood, urobilinogen, urine leukocyte esterase (ULE) test for detecting WBC (via dipstick method). The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine can be read as negative, Trace, +, ++, +++ and ++++ indicating proportional concentrations in the urine sample. The results above ++ that is ++, +++ and ++++ were reported as abnormal and the corresponding parameters were considered as abnormal parameters. Number of participants with abnormal urinalysis parameters were reported.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 37 36 34 38
Measure Type: Count of Participants
Unit of Measure: Participants
Urine Bilirubin, ++
0
   0.0%
1
   2.8%
0
   0.0%
0
   0.0%
Urine Ketones, ++
2
   5.4%
1
   2.8%
1
   2.9%
1
   2.6%
Urine Leukocyte Esterase, ++
2
   5.4%
7
  19.4%
3
   8.8%
3
   7.9%
Urine microscop-Cellular Casts, ++
1
   2.7%
1
   2.8%
0
   0.0%
0
   0.0%
Urine microscop-Culture, ++
2
   5.4%
1
   2.8%
0
   0.0%
0
   0.0%
Urine Occult Blood, ++
1
   2.7%
2
   5.6%
2
   5.9%
2
   5.3%
Urine Ketones, +++
0
   0.0%
3
   8.3%
1
   2.9%
1
   2.6%
Urine Leukocyte Esterase, +++
0
   0.0%
1
   2.8%
1
   2.9%
0
   0.0%
Urine microscopy-Culture, +++
1
   2.7%
2
   5.6%
0
   0.0%
0
   0.0%
Urine Occult Blood, +++
4
  10.8%
3
   8.3%
3
   8.8%
2
   5.3%
16.Secondary Outcome
Title Area Under Curve (AUC)(0-rescue) and AUC(0-t) of SB705498
Hide Description Cannulation of the forearm vein was performed prior to surgery for serial pharmacokinetic blood sampling. The cannula was kept patent by means of a 0.9% saline lock. Blood was sampled via the intravenous cannula with 1 mL of blood being withdrawn prior to each sample and discarded. Venipuncture was allowed if necessary (e.g., cannulation failure).
Time Frame At pre-dose on Baseline (Day 1) and at between 20-40 minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post dose and at final follow-up (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title SB705498 400 mg SB705498 1000 mg
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 34 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram*hour per milliliter (ug*h/mL)
AUC(0-rescue) Number Analyzed 32 participants 33 participants
1.6684
(82.462%)
2.2589
(82.989%)
AUC(0-t) Number Analyzed 32 participants 33 participants
3.1467
(51.813%)
4.8338
(38.963%)
17.Secondary Outcome
Title Plasma Concentrations: Average Concentration (C-avg) [0-rescue] and Maximum Concentration (C-max) of SB705498
Hide Description Cannulation of the forearm vein was performed prior to surgery for serial pharmacokinetic blood sampling. The cannula was kept patent by means of a 0.9% saline lock. Blood was sampled via the intravenous cannula with 1 mL of blood being withdrawn prior to each sample and discarded. Venipuncture was allowed if necessary (e.g., cannulation failure).
Time Frame At pre-dose on Baseline (Day 1) and at between 20-40 minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post dose and at final follow-up (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title SB705498 400 mg SB705498 1000 mg
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 32 33
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter (ug/mL)
C-avg (0-rescue)
0.3387
(42.682%)
0.5472
(36.126%)
C-max
0.5855
(43.101%)
0.8903
(41.759%)
18.Secondary Outcome
Title Time Prior to the First Measurable Concentration (T-lag) and Time to Maximum Observed Plasma Concentration (T-max)
Hide Description Cannulation of the forearm vein was performed prior to surgery for serial pharmacokinetic blood sampling. The cannula was kept patent by means of a 0.9% saline lock. Blood was sampled via the intravenous cannula with 1 mL of blood being withdrawn prior to each sample and discarded. Venipuncture was allowed if necessary (e.g., cannulation failure).
Time Frame At pre-dose (Baseline) and at between 20-40minutes and at 1, 1.5, 2, 3, 4, 6, 8, 10 hours post randomization and at final follow-up (Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title SB705498 400 mg SB705498 1000 mg
Hide Arm/Group Description:
Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.
Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.
Overall Number of Participants Analyzed 32 33
Median (Full Range)
Unit of Measure: Hour
T-lag
0.00
(0.0 to 0.5)
0.00
(0.0 to 0.0)
T-max
1.500
(1.00 to 8.15)
1.500
(1.00 to 10.15)
Time Frame Up to 28 days
Adverse Event Reporting Description Safety population was used for this analysis.
 
Arm/Group Title Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Hide Arm/Group Description Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days. Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
All-Cause Mortality
Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/36 (0.00%)   0/34 (0.00%)   0/38 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/36 (0.00%)   0/34 (0.00%)   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo SB705498 400 mg SB705498 1000 mg Co-Codamol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/37 (43.24%)   10/36 (27.78%)   14/34 (41.18%)   14/38 (36.84%) 
Cardiac disorders         
Atrioventricular block second degree  1  0/37 (0.00%)  0/36 (0.00%)  1/34 (2.94%)  1/38 (2.63%) 
Ear and labyrinth disorders         
Ear pain  1  1/37 (2.70%)  1/36 (2.78%)  0/34 (0.00%)  1/38 (2.63%) 
Eye disorders         
Asthenopia  1  1/37 (2.70%)  0/36 (0.00%)  0/34 (0.00%)  0/38 (0.00%) 
Conjunctivitis  1  0/37 (0.00%)  1/36 (2.78%)  0/34 (0.00%)  0/38 (0.00%) 
Gastrointestinal disorders         
Nausea  1  1/37 (2.70%)  1/36 (2.78%)  0/34 (0.00%)  3/38 (7.89%) 
Diarrhoea  1  1/37 (2.70%)  1/36 (2.78%)  0/34 (0.00%)  1/38 (2.63%) 
Vomiting  1  2/37 (5.41%)  0/36 (0.00%)  0/34 (0.00%)  0/38 (0.00%) 
Constipation  1  0/37 (0.00%)  0/36 (0.00%)  0/34 (0.00%)  1/38 (2.63%) 
Dyspepsia  1  0/37 (0.00%)  1/36 (2.78%)  0/34 (0.00%)  0/38 (0.00%) 
Gingival pain  1  0/37 (0.00%)  1/36 (2.78%)  0/34 (0.00%)  0/38 (0.00%) 
Mouth ulceration  1  0/37 (0.00%)  1/36 (2.78%)  0/34 (0.00%)  0/38 (0.00%) 
Toothache  1  1/37 (2.70%)  0/36 (0.00%)  0/34 (0.00%)  0/38 (0.00%) 
General disorders         
Feeling hot  1  2/37 (5.41%)  0/36 (0.00%)  2/34 (5.88%)  0/38 (0.00%) 
Pyrexia  1  0/37 (0.00%)  1/36 (2.78%)  2/34 (5.88%)  0/38 (0.00%) 
Catheter site pain  1  1/37 (2.70%)  0/36 (0.00%)  0/34 (0.00%)  0/38 (0.00%) 
Chest discomfort  1  0/37 (0.00%)  0/36 (0.00%)  1/34 (2.94%)  0/38 (0.00%) 
Feeling abnormal  1  0/37 (0.00%)  0/36 (0.00%)  0/34 (0.00%)  1/38 (2.63%) 
Feeling cold  1  0/37 (0.00%)  0/36 (0.00%)  1/34 (2.94%)  0/38 (0.00%) 
Feeling of body temperature change  1  0/37 (0.00%)  0/36 (0.00%)  1/34 (2.94%)  0/38 (0.00%) 
Influenza like illness  1  0/37 (0.00%)  1/36 (2.78%)  0/34 (0.00%)  0/38 (0.00%) 
Immune system disorders         
Seasonal allergy  1  1/37 (2.70%)  0/36 (0.00%)  0/34 (0.00%)  0/38 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  0/37 (0.00%)  1/36 (2.78%)  0/34 (0.00%)  0/38 (0.00%) 
Investigations         
ACTH stimulation test  1  0/37 (0.00%)  0/36 (0.00%)  0/34 (0.00%)  1/38 (2.63%) 
Blood bilirubin increased  1  0/37 (0.00%)  0/36 (0.00%)  0/34 (0.00%)  1/38 (2.63%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal discomfort  1  1/37 (2.70%)  0/36 (0.00%)  0/34 (0.00%)  0/38 (0.00%) 
Pain in jaw  1  1/37 (2.70%)  0/36 (0.00%)  0/34 (0.00%)  0/38 (0.00%) 
Nervous system disorders         
Headache  1  5/37 (13.51%)  1/36 (2.78%)  5/34 (14.71%)  4/38 (10.53%) 
Dizziness  1  1/37 (2.70%)  0/36 (0.00%)  0/34 (0.00%)  3/38 (7.89%) 
Dizziness postural  1  0/37 (0.00%)  0/36 (0.00%)  1/34 (2.94%)  0/38 (0.00%) 
Syncope vasovagal  1  0/37 (0.00%)  0/36 (0.00%)  0/34 (0.00%)  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders         
Pharyngolaryngeal pain  1  0/37 (0.00%)  1/36 (2.78%)  1/34 (2.94%)  1/38 (2.63%) 
Epistaxis  1  1/37 (2.70%)  0/36 (0.00%)  0/34 (0.00%)  0/38 (0.00%) 
Nasal congestion  1  0/37 (0.00%)  0/36 (0.00%)  1/34 (2.94%)  0/38 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash  1  1/37 (2.70%)  0/36 (0.00%)  1/34 (2.94%)  1/38 (2.63%) 
Vascular disorders         
Haematoma  1  0/37 (0.00%)  1/36 (2.78%)  0/34 (0.00%)  0/38 (0.00%) 
1
Term from vocabulary, MedDRA 10.1
Indicates events were collected by systematic assessment
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
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00281684     History of Changes
Other Study ID Numbers: VRA105345
First Submitted: January 23, 2006
First Posted: January 25, 2006
Results First Submitted: September 13, 2017
Results First Posted: January 28, 2019
Last Update Posted: January 28, 2019