Trial Outcomes & Findings for Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®) (NCT NCT02474407)
NCT ID: NCT02474407
Last Updated: 2018-10-16
Results Overview
Relative bioavailability based on area under time plasma concentration curve.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
24 hours
Results posted on
2018-10-16
Participant Flow
This is a randomized crossover study with 78 subjects total.
Participant milestones
| Measure |
Single Dose of Diazapam Nasal Spray (DZNS)
Subjects received a single dose diazepam nasal spray (DZNS) followed by a washout period of 14 days, after which a single dose of diazapam rectal gel (DRG) was administered.
|
Single Dose of Diazapam Rectal Gel (DRG)
Subjects received a single dose of Diazepam Rectal Gel (DRG) followed by a washout period of 14 days, after which a single dose of diazapam nasal spray (DZNS) was administered.
|
|---|---|---|
|
First Intervention (14 Days)
STARTED
|
39
|
39
|
|
First Intervention (14 Days)
COMPLETED
|
39
|
39
|
|
First Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (14 Days)
STARTED
|
39
|
39
|
|
Washout (14 Days)
COMPLETED
|
39
|
39
|
|
Washout (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (14 Days)
STARTED
|
39
|
39
|
|
Second Intervention (14 Days)
COMPLETED
|
39
|
39
|
|
Second Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioavailability, Safety and Tolerability of Diazepam Nasal Spray Versus Diazepam Rectal Gel (Diastat®)
Baseline characteristics by cohort
| Measure |
All Participants
n=78 Participants
DZNS (Diazepam Nasal Spray) vs DRG (Diazepam rectal gel)
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursRelative bioavailability based on area under time plasma concentration curve.
Outcome measures
| Measure |
Single Dose of Diazapam Nasal Spray (DZNS)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
Single Dose of Diazapam Rectal Gel (DRG)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
DZNS - At 24 Hours Post-Dose - Grade 1b
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 2
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 3
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 4
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Missing
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
|---|---|---|---|---|---|---|---|
|
AUC 0-24h
|
1357.7 ng*h/mL
Standard Deviation 802.78
|
2117.9 ng*h/mL
Standard Deviation 996.27
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hoursRelative bioavailability based on maximum observed plasma concentration.
Outcome measures
| Measure |
Single Dose of Diazapam Nasal Spray (DZNS)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
Single Dose of Diazapam Rectal Gel (DRG)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
DZNS - At 24 Hours Post-Dose - Grade 1b
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 2
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 3
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 4
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Missing
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
|---|---|---|---|---|---|---|---|
|
Cmax
|
157.0 ng/mL
Standard Deviation 120.15
|
309.3 ng/mL
Standard Deviation 137.95
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose (day 1) up to 24 hours post-dosePopulation: Safety population Cohort 1. (Accessed only for DZNS Arm)
A focused nasal exam was completed by the Investigator in the treatment period(s) when diazepam nasal spray was administered, based on a visual inspection of the nasal mucosa. Nasal irritation will be graded "none" to Grade 4 "septal perforation." Grade 1a= focal irritation, Grade 1b= superficial mucosal erosion, Grade 2= moderate mucosal erosion, Grade 3= ulceration, Grade 4= septal perforation. This exam may be conducted within a 5 minute window after the specified time point. Between the 12 and 24 h time points, the exam should be repeated every 4 hours as needed to follow any residual symptoms to resolution and the time of resolution should be documented. (Categories with no data were omitted)
Outcome measures
| Measure |
Single Dose of Diazapam Nasal Spray (DZNS)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
Single Dose of Diazapam Rectal Gel (DRG)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
DZNS - At 24 Hours Post-Dose - Grade 1b
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 2
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 3
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 4
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Missing
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
|---|---|---|---|---|---|---|---|
|
Focused Nasal Exam (Part A)
Nasal Irritation at Baseline - NONE
|
64 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Focused Nasal Exam (Part A)
Grade 1a
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Focused Nasal Exam (Part A)
Grade 1b
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Focused Nasal Exam (Part A)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: pre-dose (day 1) up to 24 hours post-dosePopulation: The Safety population / Cohort 1. (Accessed only for DZNS Arm)
A focused nasal exam was completed by the Investigator in the treatment period(s) when diazepam nasal spray was administered, based on a visual inspection of the nasal mucosa. Focused Nasal Examination Part B - will show nasal mucosal symptoms that will be rated for severity will include discharge, mucosal edema, crusting, erythema, and epistaxis. This exam may be conducted within a 5 minute window after the specified time point. Between the 12 and 24 h time points, the exam was should be repeated every 4 hours as needed to follow any residual symptoms to resolution and the time of resolution should be documented. (Categories with no data were omitted)
Outcome measures
| Measure |
Single Dose of Diazapam Nasal Spray (DZNS)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
Single Dose of Diazapam Rectal Gel (DRG)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
DZNS - At 24 Hours Post-Dose - Grade 1b
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 2
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 3
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 4
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Missing
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
|---|---|---|---|---|---|---|---|
|
Focused Nasal Exam (Part B)
Mucosal Bleeding/Epistaxis - Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
At Baseline: Mucosal Edema-None
|
70 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
Mucosal Edema - Mild
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
Mucosal Edema - Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
At Baseline: Nasal Discharge - None
|
67 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
Nasal Discharge - Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
Nasal Discharge - Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
At Baseline: Mucosal Erythema - None
|
67 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
At Baseline: Crusting of Mucosa - None
|
77 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
Mucosal Edrythema - Mild
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Focused Nasal Exam (Part B)
At Baseline: Mucosal Bleeding/Epistaxis - None
|
76 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: day 1 up to day 31Population: Safety Population / Cohort 1. (Accessed only for DZNS Arm)
The SIT is a validated test of smell identification which scores patients into different levels of olfactory function normalized by age and gender, however it had not been validated for use in PWE. The Smell Identification Test (SIT) is a 40-item multiple-choice standardized test. The test can be self-administered and consists of four 10-page booklets with a different "scratch and sniff" strip on each page. A scratch with a pencil releases the scent from the strip, and the subject is then asked to match the scent to one of four choices on the page. An answer must be selected for each of the 40 items, even when the subject cannot detect a smell. The total score (i.e., number of correct answers, range: 0-40) can be compared against normative data collected from approximately 4000 normal individuals between ages 4 to 99 to determine the subject's percentile rank of olfactory dysfunction corrected for age and gender.
Outcome measures
| Measure |
Single Dose of Diazapam Nasal Spray (DZNS)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
Single Dose of Diazapam Rectal Gel (DRG)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
DZNS - At 24 Hours Post-Dose - Grade 1b
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 2
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 3
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 4
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Missing
n=78 Participants
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
|---|---|---|---|---|---|---|---|
|
Smell Identification Test (SIT)
At BASELINE: Normosmia
|
19 Participants
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Smell Identification Test (SIT)
Mild Microsmia
|
2 Participants
|
10 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Smell Identification Test (SIT)
Moderate Microsmia
|
2 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Smell Identification Test (SIT)
Severe Microsmia
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Smell Identification Test (SIT)
Anosmia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Smell Identification Test (SIT)
Probable Malingering
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Smell Identification Test (SIT)
Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hoursPopulation: Safety Population / Cohort 1. (Accessed only for DZNS Arm)
Questionnaire given to safety population in Cohort 1 for reporting taste change during the study. If the subject spontaneously reports an experience of taste change associated with diazepam nasal spray dosing, it will be evaluated qualitatively by the research staff using a taste change questionnaire. The subject will be asked to describe the type, intensity, and duration of the change in taste at multiple scheduled time points after dosing. Between the 12 and 24 h time points, the questionnaire should be repeated every 4 hours as needed to follow any residual symptoms to resolution, and time of resolution should be documented.
Outcome measures
| Measure |
Single Dose of Diazapam Nasal Spray (DZNS)
n=78 Participants
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
Single Dose of Diazapam Rectal Gel (DRG)
Single, weight-based dose (0.2mg/kg) of DZNS and DRG administered in two randomly assigned treatment periods, separated by a minimum 14-day washout period per intervention.
|
DZNS - At 24 Hours Post-Dose - Grade 1b
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 2
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 3
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Grade 4
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
DZNS - At 24 Hours Post-Dose - Missing
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
diazepam nasal spray
|
|---|---|---|---|---|---|---|---|
|
Taste Change Questionnaire
5 mins Post-Dose
|
6.5 units on a scale
Standard Deviation 3.57
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Taste Change Questionnaire
15 mins Post-Dose
|
4.6 units on a scale
Standard Deviation 3.09
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Taste Change Questionnaire
30 mins Post Dose
|
2.8 units on a scale
Standard Deviation 2.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Taste Change Questionnaire
1 hr Post Dose
|
1.0 units on a scale
Standard Deviation 1.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Taste Change Questionnaire
2 hrs Post-Dose
|
0.3 units on a scale
Standard Deviation 0.48
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Taste Change Questionnaire
4 hrs Post-Dose
|
0.1 units on a scale
Standard Deviation 0.36
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Taste Change Questionnaire
8 hrs Post-Dose
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Taste Change Questionnaire
12 hrs Post-Dose
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Taste Change Questionnaire
24 hrs Post-Dose
|
0.0 units on a scale
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Diazepam Nasal Spray
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Diazepam Rectal Gel
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diazepam Nasal Spray
n=78 participants at risk
One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
Diazepam Nasal Spray
|
Diazepam Rectal Gel
n=78 participants at risk
A single rectal dose of diazepam will be administered to subjects according to the Diastat prescribing information.
Diazepam Rectal Gel
|
|---|---|---|
|
General disorders
Nasal Discomfort
|
38.5%
30/78 • 31 Days
|
3.8%
3/78 • 31 Days
|
|
General disorders
Dysgeusia
|
32.1%
25/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
General disorders
Lacrimation Increased
|
28.2%
22/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
General disorders
Nasal Mucosal Disorder
|
12.8%
10/78 • 31 Days
|
2.6%
2/78 • 31 Days
|
|
General disorders
Rhinorrhea
|
12.8%
10/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
General disorders
Edema Mucosal
|
10.3%
8/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
General disorders
Throat irritation
|
11.5%
9/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Nervous system disorders
Somnolence
|
5.1%
4/78 • 31 Days
|
6.4%
5/78 • 31 Days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.1%
4/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
5.1%
4/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Nervous system disorders
Headache
|
5.1%
4/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Gastrointestinal disorders
Oral dysesthesia
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
General disorders
Feeling Hot
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
General disorders
Mucosal erosion
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
General disorders
Pyrexia
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
General disorders
Secretion discharge
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Investigations
White blood cell count
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Nervous system disorders
Aura
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Nervous system disorders
Burning sensation
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Nervous system disorders
Paresthesia
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Nervous system disorders
Parosmia
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Nervous system disorders
Sinus headache
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
3/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.8%
3/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
2/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.6%
2/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/78 • 31 Days
|
1.3%
1/78 • 31 Days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.3%
1/78 • 31 Days
|
0.00%
0/78 • 31 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER