Trial Outcomes & Findings for Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity (NCT NCT01831817)
NCT ID: NCT01831817
Last Updated: 2015-03-26
Results Overview
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
COMPLETED
PHASE2
140 participants
Baseline and 4 weeks post administration of study treatment
2015-03-26
Participant Flow
Participants were recruited at the clinical site
Participants aged 18 and 55 years of age (inclusive), in good general health, with preexisting self-reported and clinically diagnosed tooth sensitivity were enrolled in this study.
Participant milestones
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
35
|
36
|
|
Overall Study
COMPLETED
|
31
|
34
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawl of Consent
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity
Baseline characteristics by cohort
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.9 Years
STANDARD_DEVIATION 10.08 • n=5 Participants
|
39.6 Years
STANDARD_DEVIATION 9.72 • n=7 Participants
|
38.3 Years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
42.7 Years
STANDARD_DEVIATION 9.10 • n=4 Participants
|
39.5 Years
STANDARD_DEVIATION 9.55 • n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks post administration of study treatmentPopulation: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
Baseline
|
2.39 Score on a scale
Standard Deviation 0.396
|
2.41 Score on a scale
Standard Deviation 0.435
|
2.40 Score on a scale
Standard Deviation 0.417
|
2.38 Score on a scale
Standard Deviation 0.403
|
|
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
Week 4
|
1.83 Score on a scale
Standard Deviation 0.779
|
1.94 Score on a scale
Standard Deviation 0.547
|
2.31 Score on a scale
Standard Deviation 0.516
|
2.31 Score on a scale
Standard Deviation 0.401
|
|
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
Mean change from baseline at Week 4
|
-0.56 Score on a scale
Standard Deviation 0.759
|
-0.47 Score on a scale
Standard Deviation 0.563
|
-0.09 Score on a scale
Standard Deviation 0.445
|
-0.07 Score on a scale
Standard Deviation 0.341
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks post administration of study treatmentPopulation: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
Baseline
|
2.40 Score on a Scale
Standard Deviation 0.396
|
2.41 Score on a Scale
Standard Deviation 0.435
|
2.40 Score on a Scale
Standard Deviation 0.417
|
2.38 Score on a Scale
Standard Deviation 0.403
|
|
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
Week 8
|
1.60 Score on a Scale
Standard Deviation 0.987
|
1.56 Score on a Scale
Standard Deviation 0.894
|
2.41 Score on a Scale
Standard Deviation 0.462
|
2.44 Score on a Scale
Standard Deviation 0.427
|
|
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
Mean change from baseline at Week 8
|
-0.81 Score on a Scale
Standard Deviation 0.972
|
-0.85 Score on a Scale
Standard Deviation 0.901
|
0.01 Score on a Scale
Standard Deviation 0.353
|
0.07 Score on a Scale
Standard Deviation 0.450
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks post administration of study treatmentPopulation: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Median Change From Baseline in Tactile Sensitivity at Week 4
Baseline
|
10.00 grams
Interval 10.0 to 10.0
|
10.00 grams
Interval 10.0 to 10.0
|
10.00 grams
Interval 10.0 to 15.0
|
10.00 grams
Interval 10.0 to 15.0
|
|
Median Change From Baseline in Tactile Sensitivity at Week 4
Week 4
|
10.00 grams
Interval 10.0 to 45.0
|
10.00 grams
Interval 10.0 to 50.0
|
10.00 grams
Interval 10.0 to 15.0
|
10.00 grams
Interval 10.0 to 35.0
|
|
Median Change From Baseline in Tactile Sensitivity at Week 4
Median change from baseline at Week 4
|
0.00 grams
Interval 0.0 to 35.0
|
0.00 grams
Interval 0.0 to 40.0
|
0.00 grams
Interval -5.0 to 5.0
|
0.00 grams
Interval -5.0 to 20.0
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks post administration of study treatmentPopulation: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Median Change From Baseline in Tactile Sensitivity at Week 8
Baseline
|
10.00 grams
Interval 10.0 to 10.0
|
10.00 grams
Interval 10.0 to 10.0
|
10.00 grams
Interval 10.0 to 15.0
|
10.00 grams
Interval 10.0 to 15.0
|
|
Median Change From Baseline in Tactile Sensitivity at Week 8
Week 8
|
15.00 grams
Interval 10.0 to 90.0
|
15.00 grams
Interval 10.0 to 75.0
|
10.00 grams
Interval 10.0 to 55.0
|
10.00 grams
Interval 10.0 to 35.0
|
|
Median Change From Baseline in Tactile Sensitivity at Week 8
Median change from baseline at Week 8
|
5.00 grams
Interval 0.0 to 80.0
|
5.00 grams
Interval 0.0 to 65.0
|
0.00 grams
Interval -5.0 to 45.0
|
0.00 grams
Interval 0.0 to 20.0
|
PRIMARY outcome
Timeframe: Baseline and 4 weeks post administration of study treatmentPopulation: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Mean Change From Baseline in Visual Rating Scale Score at Week 4
Mean change from baseline at Week 4
|
-1.20 Score on a scale
Standard Deviation 1.727
|
-0.97 Score on a scale
Standard Deviation 2.371
|
-1.03 Score on a scale
Standard Deviation 1.356
|
-0.54 Score on a scale
Standard Deviation 1.742
|
|
Mean Change From Baseline in Visual Rating Scale Score at Week 4
Baseline
|
6.66 Score on a scale
Standard Deviation 1.886
|
6.69 Score on a scale
Standard Deviation 1.723
|
6.41 Score on a scale
Standard Deviation 1.776
|
6.92 Score on a scale
Standard Deviation 1.783
|
|
Mean Change From Baseline in Visual Rating Scale Score at Week 4
Week 4
|
5.45 Score on a scale
Standard Deviation 2.212
|
5.72 Score on a scale
Standard Deviation 1.776
|
5.39 Score on a scale
Standard Deviation 1.702
|
6.38 Score on a scale
Standard Deviation 1.814
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks post administration of study treatmentPopulation: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes "No Pain" and 10 denotes "Intense Pain".
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Mean Change From Baseline in Visual Rating Scale Score at Week 8
Baseline
|
6.71 Score on a scale
Standard Deviation 1.892
|
6.69 Score on a scale
Standard Deviation 1.723
|
6.41 Score on a scale
Standard Deviation 1.776
|
6.92 Score on a scale
Standard Deviation 1.783
|
|
Mean Change From Baseline in Visual Rating Scale Score at Week 8
Week 8
|
4.65 Score on a scale
Standard Deviation 2.550
|
4.46 Score on a scale
Standard Deviation 2.076
|
5.70 Score on a scale
Standard Deviation 1.914
|
6.07 Score on a scale
Standard Deviation 2.046
|
|
Mean Change From Baseline in Visual Rating Scale Score at Week 8
Mean change from baseline at Week 8
|
-2.06 Score on a scale
Standard Deviation 2.205
|
-2.24 Score on a scale
Standard Deviation 2.287
|
-0.71 Score on a scale
Standard Deviation 1.559
|
-0.86 Score on a scale
Standard Deviation 1.673
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks post administration of study treatmentPopulation: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4
Mean change from baseline at Week 4
|
-3.91 Score on a scale
Standard Deviation 21.850
|
-4.39 Score on a scale
Standard Deviation 27.155
|
-3.80 Score on a scale
Standard Deviation 24.874
|
-7.50 Score on a scale
Standard Deviation 28.905
|
|
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4
Baseline
|
136.53 Score on a scale
Standard Deviation 34.194
|
132.55 Score on a scale
Standard Deviation 35.646
|
121.09 Score on a scale
Standard Deviation 44.467
|
133.89 Score on a scale
Standard Deviation 33.638
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks post administration of study treatmentPopulation: The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.
DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.
Outcome measures
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=32 Participants
Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate
n=34 Participants
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 Participants
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 Participants
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8
Baseline
|
134.33 Score on a scale
Standard Deviation 33.778
|
132.55 Score on a scale
Standard Deviation 35.646
|
120.09 Score on a scale
Standard Deviation 44.614
|
133.89 Score on a scale
Standard Deviation 33.638
|
|
Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8
Change from baseline at Week 8
|
-6.43 Score on a scale
Standard Deviation 28.693
|
-7.97 Score on a scale
Standard Deviation 31.324
|
-3.88 Score on a scale
Standard Deviation 22.222
|
-10.86 Score on a scale
Standard Deviation 33.669
|
Adverse Events
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
Sodium Monofluorophosphate
Sodium Fluoride
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=35 participants at risk
DDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate
n=34 participants at risk
Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
|
Sodium Monofluorophosphate
n=35 participants at risk
Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
|
Sodium Fluoride
n=36 participants at risk
Dentifrice containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
2.9%
1/35 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
2.9%
1/35 • Number of events 1
|
5.6%
2/36 • Number of events 2
|
|
Immune system disorders
Arthralgia
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
General disorders
Pain in Jaw
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
|
Infections and infestations
Oral Herpes
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
Infections and infestations
Sinusitis
|
0.00%
0/35
|
2.9%
1/34 • Number of events 1
|
0.00%
0/35
|
0.00%
0/36
|
|
Infections and infestations
Urinary Tract Infections
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
General disorders
Pain
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
Nervous system disorders
Sinus Headache
|
2.9%
1/35 • Number of events 2
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
5.7%
2/35 • Number of events 3
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.00%
0/35
|
0.00%
0/34
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
2.9%
1/35 • Number of events 1
|
0.00%
0/34
|
0.00%
0/35
|
2.8%
1/36 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/35
|
0.00%
0/34
|
2.9%
1/35 • Number of events 1
|
0.00%
0/36
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER