Trial Outcomes & Findings for Guanfacine Immediate-release Electrocardiogram Results (QTc) Study (NCT NCT00672984)
NCT ID: NCT00672984
Last Updated: 2021-06-14
Results Overview
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
83 participants
Primary outcome timeframe
Baseline and Tmax (time of subject-specific maximum plasma concentration)
Results posted on
2021-06-14
Participant Flow
This is a three period crossover trial.
Participant milestones
| Measure |
Guanfacine First
Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
|
Moxifloxacin First
Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
|
Placebo First
Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
|
|---|---|---|---|
|
First Intervention
STARTED
|
31
|
25
|
27
|
|
First Intervention
COMPLETED
|
22
|
23
|
25
|
|
First Intervention
NOT COMPLETED
|
9
|
2
|
2
|
|
Second Intervention
STARTED
|
22
|
23
|
25
|
|
Second Intervention
COMPLETED
|
22
|
17
|
24
|
|
Second Intervention
NOT COMPLETED
|
0
|
6
|
1
|
|
Third Intervention
STARTED
|
22
|
17
|
24
|
|
Third Intervention
COMPLETED
|
21
|
17
|
23
|
|
Third Intervention
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Guanfacine First
Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
|
Moxifloxacin First
Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
|
Placebo First
Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
|
|---|---|---|---|
|
First Intervention
Adverse Event
|
5
|
0
|
0
|
|
First Intervention
Withdrawal by Subject
|
1
|
2
|
2
|
|
First Intervention
Sponsor decision
|
3
|
0
|
0
|
|
Second Intervention
Non-compliance with facility policies
|
0
|
2
|
0
|
|
Second Intervention
Withdrawal by Subject
|
0
|
3
|
0
|
|
Second Intervention
Protocol Violation
|
0
|
1
|
1
|
|
Third Intervention
Adverse Event
|
1
|
0
|
1
|
Baseline Characteristics
Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
Baseline characteristics by cohort
| Measure |
Guanfacine First
n=31 Participants
Single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in first intervention period; single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in second intervention period (after washout period); single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in third intervention period (after washout period).
|
Moxifloxacin First
n=25 Participants
Single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in first intervention period; single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in second intervention period (after washout period); single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in third intervention period (after washout period).
|
Placebo First
n=27 Participants
Single dose of placebo on Day 1, placebo bid on Days 2, 3, 4, and 5, and single dose of placebo on Day 6 in first intervention period; single 4 mg dose of immediate-release Guanfacine HCl on Day 1, 4 mg of immediate-release Guanfacine HCl bid on Days 2 and 3, 6 mg of immediate-release Guanfacine HCl bid on Days 4 and 5, and a single 8 mg dose of immediate-release Guanfacine HCl on Day 6 in second intervention period (after washout period); single 400 mg dose of Moxifloxacin on Day 1, placebo bid on Days 2, 3, 4, and 5, and single 400 mg dose of Moxifloxacin on Day 6 in third intervention period (after washout period).
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 7.55 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 10.02 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 8.71 • n=5 Participants
|
29.4 years
STANDARD_DEVIATION 8.61 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Tmax (time of subject-specific maximum plasma concentration)Population: Pharmacodynamic (PD) population consists of all evaluable subjects with no major protocol deviations. "Evaluable" subjects were defined as subjects who received a Day 6 dose and had Day 6 data for the primary and secondary endpoints for all three periods.
QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Outcome measures
| Measure |
Guanfacine 4 mg
n=57 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=58 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
n=57 Participants
|
Placebo (Moxifloxacin)
n=58 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram Results (QTcNi) at Time of Maximum Plasma Concentration (Tmax) on Day 1
|
-3.37 msec
Standard Error 1.00 • Interval -4.52 to -0.34
|
12.96 msec
Standard Error 1.03 • Interval 11.45 to 16.29
|
-0.94 msec
Standard Error 1.02
|
-0.91 msec
Standard Error 1.04
|
PRIMARY outcome
Timeframe: Baseline and Tmax (time of subject-specific maximum plasma concentration)Population: PD population
QTcNi is the QT interval using a subject-specific correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Outcome measures
| Measure |
Guanfacine 4 mg
n=58 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=45 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
n=58 Participants
|
Placebo (Moxifloxacin)
n=44 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram Results (QTcNi) at Tmax on Day 6
|
-12.45 msec
Standard Error 1.50 • Interval -11.37 to -4.78
|
8.99 msec
Standard Error 1.79 • Interval 9.33 to 16.93
|
-4.37 msec
Standard Error 1.52
|
-4.13 msec
Standard Error 1.84
|
PRIMARY outcome
Timeframe: Baseline and Tmax (time of subject-specific maximum plasma concentration)Population: PD population
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Outcome measures
| Measure |
Guanfacine 4 mg
n=57 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=58 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
n=57 Participants
|
Placebo (Moxifloxacin)
n=58 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 1
|
0.15 msec
Standard Error 0.96 • Interval -1.07 to 3.03
|
9.96 msec
Standard Error 0.92 • Interval 8.97 to 13.24
|
-0.83 msec
Standard Error 0.97
|
-1.14 msec
Standard Error 0.92
|
PRIMARY outcome
Timeframe: Baseline and Tmax (time of subject-specific maximum plasma concentration)Population: PD population
QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Outcome measures
| Measure |
Guanfacine 4 mg
n=58 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=45 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
n=58 Participants
|
Placebo (Moxifloxacin)
n=44 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram Results (QTcF) at Tmax on Day 6
|
-2.67 msec
Standard Error 1.24 • Interval -0.99 to 4.27
|
6.44 msec
Standard Error 1.65 • Interval 7.63 to 13.97
|
-4.31 msec
Standard Error 1.25
|
-4.35 msec
Standard Error 1.68
|
PRIMARY outcome
Timeframe: Baseline and Tmax (time of subject-specific maximum plasma concentration)Population: PD population
Outcome measures
| Measure |
Guanfacine 4 mg
n=57 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=58 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
n=57 Participants
|
Placebo (Moxifloxacin)
n=58 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate (HR) at Tmax on Day 1
|
-7.18 bpm
Standard Error 0.58 • Interval -8.01 to -5.51
|
5.46 bpm
Standard Error 0.79 • Interval 3.08 to 6.38
|
-0.42 bpm
Standard Error 0.58
|
0.73 bpm
Standard Error 0.79
|
PRIMARY outcome
Timeframe: Baseline and Tmax (time of subject-specific maximum plasma concentration)Population: PD population
Outcome measures
| Measure |
Guanfacine 4 mg
n=58 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=45 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
n=58 Participants
|
Placebo (Moxifloxacin)
n=44 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Heart Rate (HR) at Tmax on Day 6
|
-19.74 bpm
Standard Error 0.89 • Interval -21.92 to -17.78
|
4.66 bpm
Standard Error 0.83 • Interval 1.77 to 5.11
|
0.11 bpm
Standard Error 0.89
|
1.22 bpm
Standard Error 0.85
|
PRIMARY outcome
Timeframe: Baseline and Tmax (time of subject-specific maximum plasma concentration)Population: PD population
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).
Outcome measures
| Measure |
Guanfacine 4 mg
n=57 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=58 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
n=57 Participants
|
Placebo (Moxifloxacin)
n=58 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 1
|
15.88 msec
Standard Error 1.63 • Interval 11.75 to 18.89
|
-1.27 msec
Standard Error 1.74 • Interval -2.77 to 4.63
|
0.56 msec
Standard Error 1.63
|
-2.20 msec
Standard Error 1.74
|
PRIMARY outcome
Timeframe: Baseline and Tmax (time of subject-specific maximum plasma concentration)Population: PD population
QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval).
Outcome measures
| Measure |
Guanfacine 4 mg
n=58 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=45 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
n=58 Participants
|
Placebo (Moxifloxacin)
n=44 Participants
|
|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram Results (QT) Interval at Tmax on Day 6
|
46.21 msec
Standard Error 2.40 • Interval 44.71 to 54.98
|
-3.09 msec
Standard Error 2.15 • Interval -0.41 to 7.66
|
-3.63 msec
Standard Error 2.40
|
-6.71 msec
Standard Error 2.19
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dosePopulation: Pharmacokinetic (PK) population consists of all subjects in the safety population (subjects who had taken one dose of study medication and had one follow-up safety assessment completed) who had evaluable concentration-time profiles.
Outcome measures
| Measure |
Guanfacine 4 mg
n=76 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=72 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
|
Placebo (Moxifloxacin)
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 1
|
8.51 ng/ml
Standard Deviation 1.77
|
1943.1 ng/ml
Standard Deviation 463.8
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dosePopulation: PK population
Outcome measures
| Measure |
Guanfacine 4 mg
n=64 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=57 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
|
Placebo (Moxifloxacin)
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Guanfacine and Moxifloxacin on Day 6
|
24.70 ng/ml
Standard Deviation 6.10
|
2003.4 ng/ml
Standard Deviation 477.4
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dosePopulation: PK population
Outcome measures
| Measure |
Guanfacine 4 mg
n=76 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=72 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
|
Placebo (Moxifloxacin)
|
|---|---|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 1
|
3.9 hours
Standard Deviation 1.9
|
2.13 hours
Standard Deviation 1.08
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dosePopulation: PK population
Outcome measures
| Measure |
Guanfacine 4 mg
n=64 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=57 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
|
Placebo (Moxifloxacin)
|
|---|---|---|---|---|
|
Time of Maximum Plasma Concentration (Tmax) of Guanfacine and Moxifloxacin on Day 6
|
5.2 hours
Standard Deviation 2.3
|
1.78 hours
Standard Deviation 0.89
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dosePopulation: PK population
Outcome measures
| Measure |
Guanfacine 4 mg
n=76 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=72 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
|
Placebo (Moxifloxacin)
|
|---|---|---|---|---|
|
Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 1
|
110.8 ng.h/ml
Standard Deviation 24.4
|
19892 ng.h/ml
Standard Deviation 4670
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dosePopulation: PK population
Outcome measures
| Measure |
Guanfacine 4 mg
n=64 Participants
4 mg Immediate-release Guanfacine HCl
|
Moxifloxacin
n=57 Participants
400 mg Avelox, positive control
|
Placebo (Guanfacine)
|
Placebo (Moxifloxacin)
|
|---|---|---|---|---|
|
Area Under the Steady-state Plasma Concentration-time Curve (AUC) for Guanfacine and Moxifloxacin on Day 6
|
370.3 ng.h/ml
Standard Deviation 101.3
|
20767 ng.h/ml
Standard Deviation 4396
|
—
|
—
|
Adverse Events
Guanfacine
Serious events: 5 serious events
Other events: 76 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Guanfacine
n=76 participants at risk
Immediate-release Guanfacine HCl
|
Moxifloxacin
n=72 participants at risk
Avelox, positive control
|
Placebo
n=68 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/76
|
0.00%
0/72
|
0.00%
0/68
|
|
Gastrointestinal disorders
Ileus
|
1.3%
1/76
|
0.00%
0/72
|
0.00%
0/68
|
|
Nervous system disorders
Syncope
|
2.6%
2/76
|
0.00%
0/72
|
0.00%
0/68
|
|
Nervous system disorders
Syncope vasovagal
|
1.3%
1/76
|
0.00%
0/72
|
0.00%
0/68
|
|
Vascular disorders
Orthostatic hypotension
|
1.3%
1/76
|
0.00%
0/72
|
0.00%
0/68
|
Other adverse events
| Measure |
Guanfacine
n=76 participants at risk
Immediate-release Guanfacine HCl
|
Moxifloxacin
n=72 participants at risk
Avelox, positive control
|
Placebo
n=68 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
65.8%
50/76
|
2.8%
2/72
|
0.00%
0/68
|
|
Nervous system disorders
Dizziness
|
61.8%
47/76
|
8.3%
6/72
|
7.4%
5/68
|
|
General disorders
Asthenia
|
56.6%
43/76
|
8.3%
6/72
|
1.5%
1/68
|
|
Gastrointestinal disorders
Constipation
|
42.1%
32/76
|
5.6%
4/72
|
4.4%
3/68
|
|
Nervous system disorders
Headache
|
30.3%
23/76
|
11.1%
8/72
|
22.1%
15/68
|
|
Gastrointestinal disorders
Nausea
|
17.1%
13/76
|
19.4%
14/72
|
7.4%
5/68
|
|
Ear and labyrinth disorders
Tinnitus
|
15.8%
12/76
|
1.4%
1/72
|
0.00%
0/68
|
|
Eye disorders
Vision blurred
|
13.2%
10/76
|
0.00%
0/72
|
4.4%
3/68
|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
8/76
|
6.9%
5/72
|
1.5%
1/68
|
|
Eye disorders
Dry eye
|
10.5%
8/76
|
5.6%
4/72
|
1.5%
1/68
|
|
General disorders
Mucosal dryness
|
10.5%
8/76
|
0.00%
0/72
|
1.5%
1/68
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
9.2%
7/76
|
0.00%
0/72
|
1.5%
1/68
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.9%
6/76
|
0.00%
0/72
|
1.5%
1/68
|
|
Psychiatric disorders
Insomnia
|
7.9%
6/76
|
1.4%
1/72
|
0.00%
0/68
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.9%
6/76
|
0.00%
0/72
|
4.4%
3/68
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
6/76
|
5.6%
4/72
|
2.9%
2/68
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.6%
5/76
|
11.1%
8/72
|
13.2%
9/68
|
|
Gastrointestinal disorders
Diarrhea
|
6.6%
5/76
|
2.8%
2/72
|
2.9%
2/68
|
|
Gastrointestinal disorders
Dyspepsia
|
6.6%
5/76
|
1.4%
1/72
|
4.4%
3/68
|
|
General disorders
Fatigue
|
6.6%
5/76
|
1.4%
1/72
|
0.00%
0/68
|
|
Ear and labyrinth disorders
Hypoacusis
|
6.6%
5/76
|
1.4%
1/72
|
0.00%
0/68
|
|
Nervous system disorders
Paresthesia
|
6.6%
5/76
|
1.4%
1/72
|
0.00%
0/68
|
|
Eye disorders
Scotoma
|
6.6%
5/76
|
0.00%
0/72
|
0.00%
0/68
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
4/76
|
1.4%
1/72
|
1.5%
1/68
|
|
Psychiatric disorders
Anxiety
|
5.3%
4/76
|
0.00%
0/72
|
0.00%
0/68
|
|
Vascular disorders
Hot flush
|
5.3%
4/76
|
1.4%
1/72
|
1.5%
1/68
|
|
Vascular disorders
Hypotension
|
5.3%
4/76
|
0.00%
0/72
|
0.00%
0/68
|
|
General disorders
Irritability
|
5.3%
4/76
|
1.4%
1/72
|
1.5%
1/68
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually
- Publication restrictions are in place
Restriction type: OTHER