Trial Outcomes & Findings for Intra Oral Kinetics of Fluoride Containing Dentifrices (NCT NCT02548156)
NCT ID: NCT02548156
Last Updated: 2017-01-18
Results Overview
Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
60 minutes
Results posted on
2017-01-18
Participant Flow
Participants were recruited at one Centre United Kingdom.
A total of 59 participants were screened, out of which 29 were randomized. Of the 29 randomized participants, 28 completed the study.
Participant milestones
| Measure |
Sequence 1: Test/Comparator/Reference: Dentifrice
Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 2: Test/Reference/Comparator: Dentifrice
Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 3: Comparator/Test/Reference: Dentifrice
Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 4: Comparator/Reference/Test: Dentifrice
Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 5: Reference/Test/Comparator: Dentifrice
Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 6: Reference/Comparator/Test: Dentifrice
Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Period 1
COMPLETED
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
5
|
5
|
4
|
5
|
5
|
5
|
|
Washout Period 1
COMPLETED
|
5
|
5
|
4
|
5
|
4
|
5
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
5
|
5
|
4
|
5
|
4
|
5
|
|
Period 2
COMPLETED
|
5
|
5
|
4
|
5
|
4
|
5
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
5
|
5
|
4
|
5
|
4
|
5
|
|
Washout Period 2
COMPLETED
|
5
|
5
|
4
|
5
|
4
|
5
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
5
|
5
|
4
|
5
|
4
|
5
|
|
Period 3
COMPLETED
|
5
|
5
|
4
|
5
|
4
|
5
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Test/Comparator/Reference: Dentifrice
Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 2: Test/Reference/Comparator: Dentifrice
Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 3: Comparator/Test/Reference: Dentifrice
Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 4: Comparator/Reference/Test: Dentifrice
Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 5: Reference/Test/Comparator: Dentifrice
Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
Sequence 6: Reference/Comparator/Test: Dentifrice
Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
|
|---|---|---|---|---|---|---|
|
Washout Period 1
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Intra Oral Kinetics of Fluoride Containing Dentifrices
Baseline characteristics by cohort
| Measure |
Overall Study
n=29 Participants
All the participants randomized in this study.
|
|---|---|
|
Age, Continuous
|
34.8 Years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
|
Gender
Female
|
23 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.
Outcome measures
| Measure |
Test Dentifrice
n=28 Participants
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
Reference Dentifrice
n=28 Participants
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
|
Comparator Dentifrice
n=28 Participants
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
|---|---|---|---|
|
Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse
|
0.23 parts per million(ppm)
Standard Error 0.0469
|
0.23 parts per million(ppm)
Standard Error 0.0430
|
0.15 parts per million(ppm)
Standard Error 0.0485
|
SECONDARY outcome
Timeframe: up to 60 minutesPopulation: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice
Outcome measures
| Measure |
Test Dentifrice
n=28 Participants
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
Reference Dentifrice
n=28 Participants
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
|
Comparator Dentifrice
n=28 Participants
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
|---|---|---|---|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Fluoride: At baseline (n=26, 28, 26)
|
0.045 ppm
Standard Error 0.0125
|
0.032 ppm
Standard Error 0.0084
|
0.031 ppm
Standard Error 0.0072
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Fluoride: At 1 minute (n=27, 28, 26)
|
8.775 ppm
Standard Error 0.8301
|
8.794 ppm
Standard Error 1.0562
|
7.630 ppm
Standard Error 0.7497
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Fluoride: At 5 minute (n=27, 27, 27)
|
3.881 ppm
Standard Error 0.4115
|
4.132 ppm
Standard Error 0.4759
|
3.492 ppm
Standard Error 0.4664
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Fluoride: At 10 minute (n=26, 26, 26)
|
1.831 ppm
Standard Error 0.1980
|
1.951 ppm
Standard Error 0.2654
|
1.476 ppm
Standard Error 0.1524
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Fluoride: At 15 minute (n=27, 27, 26)
|
1.346 ppm
Standard Error 0.1827
|
1.188 ppm
Standard Error 0.1550
|
0.942 ppm
Standard Error 0.1432
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Fluoride: At 30 minute (n=26, 27, 27)
|
0.656 ppm
Standard Error 0.1065
|
0.600 ppm
Standard Error 0.0810
|
0.479 ppm
Standard Error 0.0723
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Calcium: At Baseline (n=26, 25, 22)
|
29.749 ppm
Standard Error 0.9428
|
28.357 ppm
Standard Error 1.0162
|
28.661 ppm
Standard Error 1.0657
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Calcium: At 1 minute (n=23, 28, 25)
|
28.300 ppm
Standard Error 1.5171
|
27.217 ppm
Standard Error 1.0689
|
14.931 ppm
Standard Error 1.0999
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Calcium: At 5 minute (n=16, 17, 22)
|
27.818 ppm
Standard Error 1.3743
|
26.070 ppm
Standard Error 1.4638
|
17.227 ppm
Standard Error 0.9170
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Calcium: At 10 minute (n=16, 16, 21)
|
27.472 ppm
Standard Error 1.0061
|
25.672 ppm
Standard Error 1.1944
|
20.133 ppm
Standard Error 1.0395
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Calcium: At 15 minute (n=18, 20, 20)
|
28.319 ppm
Standard Error 1.0783
|
27.227 ppm
Standard Error 0.8656
|
23.761 ppm
Standard Error 1.2803
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Calcium: At 30 minute (n=17, 18, 20)
|
28.650 ppm
Standard Error 1.0725
|
27.323 ppm
Standard Error 1.0325
|
24.196 ppm
Standard Error 1.3196
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Calcium: At 60 minute (n=23, 20, 22)
|
28.198 ppm
Standard Error 1.0073
|
27.094 ppm
Standard Error 1.0560
|
27.104 ppm
Standard Error 1.3777
|
SECONDARY outcome
Timeframe: 60 minutesPopulation: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice
Outcome measures
| Measure |
Test Dentifrice
n=28 Participants
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
Reference Dentifrice
n=28 Participants
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
|
Comparator Dentifrice
n=28 Participants
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
|---|---|---|---|
|
Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse
Fluoride Ion concentration(n=27, 28, 27)
|
0.349 ppm
Standard Error 0.0349
|
0.169 ppm
Standard Error 0.1104
|
0.277 ppm
Standard Error 0.1601
|
|
Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse
Calcium Ion concentration (n=26, 22, 25)
|
15.015 ppm
Standard Error 4.3355
|
27.263 ppm
Standard Error 4.7113
|
14.805 ppm
Standard Error 4.0473
|
SECONDARY outcome
Timeframe: up to 60 minutesPopulation: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.
Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse
Outcome measures
| Measure |
Test Dentifrice
n=28 Participants
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
Reference Dentifrice
n=28 Participants
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
|
Comparator Dentifrice
n=28 Participants
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
|---|---|---|---|
|
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Fluoride: In initial expectorate
|
178.522 ppm
Standard Deviation 61.1593
|
168.728 ppm
Standard Deviation 54.3780
|
164.708 ppm
Standard Deviation 54.2632
|
|
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Fluoride: Post-Brushing De-Ionised Water Rinse Ex
|
8.377 ppm
Standard Deviation 4.2346
|
7.721 ppm
Standard Deviation 4.1721
|
7.443 ppm
Standard Deviation 3.4546
|
|
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Fluoride: 60 Minutes Post Brushing
|
0.166 ppm
Standard Deviation 0.0609
|
0.046 ppm
Standard Deviation 0.0370
|
0.135 ppm
Standard Deviation 0.0563
|
|
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Calcium: In initial expectorate
|
17.096 ppm
Standard Deviation 4.7864
|
17.467 ppm
Standard Deviation 4.1241
|
2.500 ppm
Standard Deviation 0.0000
|
|
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Calcium: Post-Brushing De-Ionised Water Rinse Ex
|
4.959 ppm
Standard Deviation 2.2712
|
4.438 ppm
Standard Deviation 2.2141
|
2.500 ppm
Standard Deviation 0.0000
|
|
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Calcium: 60 Minutes Post Brushing
|
96.165 ppm
Standard Deviation 9.2357
|
4.600 ppm
Standard Deviation 2.0507
|
99.189 ppm
Standard Deviation 17.2771
|
Adverse Events
Test Dentifrice
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Reference Dentifrice
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Comparator Dentifrice
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Dentifrice
n=28 participants at risk
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
Reference Dentifrice
n=29 participants at risk
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
|
Comparator Dentifrice
n=28 participants at risk
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
|
|---|---|---|---|
|
Gastrointestinal disorders
Chapped Lips
|
3.6%
1/28
|
0.00%
0/29
|
0.00%
0/28
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28
|
0.00%
0/29
|
0.00%
0/28
|
|
General disorders
Device failure
|
3.6%
1/28
|
0.00%
0/29
|
0.00%
0/28
|
|
General disorders
Medical device complication
|
3.6%
1/28
|
0.00%
0/29
|
0.00%
0/28
|
|
General disorders
Malaise
|
0.00%
0/28
|
3.4%
1/29
|
0.00%
0/28
|
|
General disorders
Vaccination site pain
|
0.00%
0/28
|
3.4%
1/29
|
0.00%
0/28
|
|
Infections and infestations
Influenza
|
0.00%
0/28
|
0.00%
0/29
|
3.6%
1/28
|
|
Infections and infestations
Oral herpes
|
0.00%
0/28
|
0.00%
0/29
|
7.1%
2/28
|
|
Infections and infestations
Rhinitis
|
0.00%
0/28
|
0.00%
0/29
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Mouth injury
|
7.1%
2/28
|
0.00%
0/29
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/28
|
3.4%
1/29
|
0.00%
0/28
|
|
Nervous system disorders
Headache
|
3.6%
1/28
|
0.00%
0/29
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.6%
1/28
|
0.00%
0/29
|
0.00%
0/28
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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