Trial Outcomes & Findings for Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients (NCT NCT01844830)
NCT ID: NCT01844830
Last Updated: 2017-08-30
Results Overview
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window
Results posted on
2017-08-30
Participant Flow
Participant milestones
| Measure |
Kovacaine Mist
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
|
Overall Study
100 µL Dose
|
16
|
8
|
|
Overall Study
200 µL Dose
|
24
|
12
|
|
Overall Study
400 µL Dose
|
20
|
10
|
|
Overall Study
COMPLETED
|
59
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Kovacaine Mist
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.3 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
8.1 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
8.2 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute windowIf the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
Outcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
|
46 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute windowPopulation: Subjects were in only 1 of 3 dosage cohort. Either 100 µL, 200 µL, or 400 µL.
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
Outcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.
100 µL
|
14 Participants
|
7 Participants
|
|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.
200 µL
|
14 Participants
|
5 Participants
|
|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.
400 µL
|
18 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute windowPopulation: Patients are grouped by age
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
Outcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).
3 to 5 years
|
17 Participants
|
8 Participants
|
|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).
6 to 11 years
|
14 Participants
|
6 Participants
|
|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).
12 to 17 years
|
15 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: from baseline to 24 hours following drug administrationPopulation: Patients grouped by dosage cohort
Patients with AEs
Outcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Incidence of Adverse Events (AEs) by Dosage Cohort
100 µL
|
12 Count of participants
|
6 Count of participants
|
|
Incidence of Adverse Events (AEs) by Dosage Cohort
200 µL
|
22 Count of participants
|
9 Count of participants
|
|
Incidence of Adverse Events (AEs) by Dosage Cohort
400 µL
|
15 Count of participants
|
7 Count of participants
|
SECONDARY outcome
Timeframe: from baseline to 24 hours following drug administrationPopulation: Patients group by age
Patients with AEs
Outcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Incidence of Adverse Events (AEs) by Age Group
3 to 5 years
|
17 Count of participants
|
7 Count of participants
|
|
Incidence of Adverse Events (AEs) by Age Group
6 to 11 years
|
19 Count of participants
|
11 Count of participants
|
|
Incidence of Adverse Events (AEs) by Age Group
12 to 17 years
|
13 Count of participants
|
4 Count of participants
|
SECONDARY outcome
Timeframe: 120 minutes post drug administrationThe investigators evaluated the treatment naris for patency and ulcerations. Patency was evaluated as followed: The nostril not used for dosing study drug was manually occluded and the subject was asked to sniff gently. Airflow in the naris was used to determine if it was patent (yes) or not (no). For ulcers, the investigators performed a visual examination for the presence of ulcers and recorded if they were present (yes) or not (no).
Outcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Results of Naris Examination (NE) - Patency and Ulcerations
Patency (yes)
|
59 Participants
|
30 Participants
|
|
Results of Naris Examination (NE) - Patency and Ulcerations
Ulcerations (yes)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from baseline to 24 hours following drug administrationOutcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Maximum Change From Baseline in Heart Rate
|
5.6 bpm
Standard Deviation 9.09
|
6.9 bpm
Standard Deviation 9.99
|
SECONDARY outcome
Timeframe: from baseline to 24 hours following drug administrationOutcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Maximum Change From Baseline in Systolic Blood Pressure
|
5.4 mmHg
Standard Deviation 8.78
|
1.0 mmHg
Standard Deviation 8.70
|
SECONDARY outcome
Timeframe: from baseline to 24 hours following drug administrationOutcome measures
| Measure |
Kovacaine Mist
n=60 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Maximum Change From Baseline in Diastolic Blood Pressure
|
8.3 mmHg
Standard Deviation 8.11
|
2.4 mmHg
Standard Deviation 7.09
|
SECONDARY outcome
Timeframe: 120 minutes post drug administrationThe investigators performed a visual inspection and evaluated the treatment naris for color of the mucosa. The investigator determined what color (Pink, Slightly Red, Red) best matched and recorded the results.
Outcome measures
| Measure |
Kovacaine Mist
n=59 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Results of Naris Examination (NE) - Color
Pink
|
52 Participants
|
25 Participants
|
|
Results of Naris Examination (NE) - Color
Slightly Red
|
6 Participants
|
5 Participants
|
|
Results of Naris Examination (NE) - Color
Red
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 120 minutes post drug administrationOutcome measures
| Measure |
Kovacaine Mist
n=59 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Results of Naris Examination (NE) - Inflammation
No Inflammation
|
57 Participants
|
29 Participants
|
|
Results of Naris Examination (NE) - Inflammation
Slight Inflammation
|
2 Participants
|
1 Participants
|
|
Results of Naris Examination (NE) - Inflammation
Inflammation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 120 minutes post drug administrationOutcome measures
| Measure |
Kovacaine Mist
n=59 Participants
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 Participants
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Results of Naris Examination (NE) - Bleeding
None
|
57 Participants
|
29 Participants
|
|
Results of Naris Examination (NE) - Bleeding
Slight / Minor
|
2 Participants
|
1 Participants
|
|
Results of Naris Examination (NE) - Bleeding
Significant / Major
|
0 Participants
|
0 Participants
|
Adverse Events
Kovacaine Mist
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Kovacaine Mist
n=60 participants at risk
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: Intranasally administered regional anesthetic
|
Placebo
n=30 participants at risk
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
Placebo: Inactive ingredients supplied in identical nasal sprayer
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
15/60
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
25.0%
15/60
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
13.3%
8/60
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
10.0%
6/60
|
10.0%
3/30
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.0%
6/60
|
6.7%
2/30
|
|
Nervous system disorders
Headache
|
5.0%
3/60
|
3.3%
1/30
|
|
Eye disorders
Lacrimation increased
|
28.3%
17/60
|
20.0%
6/30
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Hypoaesthesia
|
5.0%
3/60
|
0.00%
0/30
|
|
General disorders
Injection Site Pain
|
11.7%
7/60
|
23.3%
7/30
|
|
General disorders
Injection Site Anaesthesia
|
6.7%
4/60
|
26.7%
8/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place