Trial Outcomes & Findings for A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients (NCT NCT01499368)
NCT ID: NCT01499368
Last Updated: 2025-01-15
Results Overview
Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
495 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-01-15
Participant Flow
Participant milestones
| Measure |
Lafutidine
Lafutidine 20mg/day
Lafutidine 10mg bid, po
|
Famotidine
Famotidine 40mg/day
Famotidine 20mg bid, po
|
Omeprazole
Omeprazole 20mg/day
Omeprazole 20mg qd(daily), po
|
|---|---|---|---|
|
Overall Study
STARTED
|
165
|
163
|
167
|
|
Overall Study
COMPLETED
|
138
|
145
|
146
|
|
Overall Study
NOT COMPLETED
|
27
|
18
|
21
|
Reasons for withdrawal
| Measure |
Lafutidine
Lafutidine 20mg/day
Lafutidine 10mg bid, po
|
Famotidine
Famotidine 40mg/day
Famotidine 20mg bid, po
|
Omeprazole
Omeprazole 20mg/day
Omeprazole 20mg qd(daily), po
|
|---|---|---|---|
|
Overall Study
Did not meet I/E criteria
|
8
|
4
|
4
|
|
Overall Study
Prohibited Concomitant medication
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
10
|
8
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
5
|
|
Overall Study
Adverse Event
|
4
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Deviation from visit window
|
0
|
0
|
1
|
|
Overall Study
Error of Prescriptions
|
0
|
0
|
1
|
Baseline Characteristics
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
Baseline characteristics by cohort
| Measure |
Lafutidine
n=165 Participants
Lafutidine 20mg/day
Lafutidine: Lafutidine 20mg/day
|
Famotidine
n=162 Participants
Famotidine 40mg/day
Famotidine: Famotidine 40mg/day
|
Omeprazole
n=167 Participants
Omeprazole 20mg/day
Omeprazole: Omeprazole 20mg/day
|
Total
n=494 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
40 years ~ 49 years
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Age, Customized
50 years ~ 59 years
|
55 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Age, Customized
60 years ~ 69 years
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Age, Customized
70 years ~ 74 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
340 Participants
n=4 Participants
|
|
Age, Continuous
Age, Mean+-STD (years)
|
50.20 years
STANDARD_DEVIATION 13.57 • n=5 Participants
|
51.25 years
STANDARD_DEVIATION 12.76 • n=7 Participants
|
49.65 years
STANDARD_DEVIATION 13.84 • n=5 Participants
|
50.36 years
STANDARD_DEVIATION 13.39 • n=4 Participants
|
|
Age, Continuous
|
53.00 years
n=5 Participants
|
53.00 years
n=7 Participants
|
50.00 years
n=5 Participants
|
52.00 years
n=4 Participants
|
|
Age, Customized
20 years~ 29 years
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Customized
30 years ~ 39 years
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksRecovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS
Outcome measures
| Measure |
Lafutidine
n=144 Participants
Lafutidine 20mg/day
Lafutidine 10mg bid, po
|
Famotidine
n=145 Participants
Famotidine 40mg/day
Famotidine 20mg bid, po
|
Omeprazole
n=147 Participants
Omeprazole 20mg/day
Omeprazole 20mg qd(daily), po
|
|---|---|---|---|
|
Recovery Rates of Reflux Esophagitis
Recovered
|
101 Participants
|
92 Participants
|
126 Participants
|
|
Recovery Rates of Reflux Esophagitis
Not recovered
|
43 Participants
|
53 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 4 or 8 weekPopulation: Missing = Lafutidine(5) , Omeprazole(1)
The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain
Outcome measures
| Measure |
Lafutidine
n=139 Participants
Lafutidine 20mg/day
Lafutidine 10mg bid, po
|
Famotidine
n=145 Participants
Famotidine 40mg/day
Famotidine 20mg bid, po
|
Omeprazole
n=146 Participants
Omeprazole 20mg/day
Omeprazole 20mg qd(daily), po
|
|---|---|---|---|
|
The Proportion of Days Without 'Cardinal Symptom'
week 8
|
0.77 proportion of days
Standard Deviation 0.27
|
0.67 proportion of days
Standard Deviation 0.32
|
0.82 proportion of days
Standard Deviation 0.24
|
|
The Proportion of Days Without 'Cardinal Symptom'
week 8(LOCF)
|
0.77 proportion of days
Standard Deviation 0.27
|
0.67 proportion of days
Standard Deviation 0.32
|
0.82 proportion of days
Standard Deviation 0.24
|
|
The Proportion of Days Without 'Cardinal Symptom'
week 4
|
0.64 proportion of days
Standard Deviation 0.31
|
0.56 proportion of days
Standard Deviation 0.32
|
0.69 proportion of days
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: 4 or 8 weekPopulation: Missing = Lafutidine(5) , Omeprazole(1)
The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain
Outcome measures
| Measure |
Lafutidine
n=139 Participants
Lafutidine 20mg/day
Lafutidine 10mg bid, po
|
Famotidine
n=145 Participants
Famotidine 40mg/day
Famotidine 20mg bid, po
|
Omeprazole
n=146 Participants
Omeprazole 20mg/day
Omeprazole 20mg qd(daily), po
|
|---|---|---|---|
|
The Proportion of Daytimes Without 'Cardinal Symptom'
week 4
|
0.74 proportion of days
Standard Deviation 0.27
|
0.68 proportion of days
Standard Deviation 0.29
|
0.77 proportion of days
Standard Deviation 0.27
|
|
The Proportion of Daytimes Without 'Cardinal Symptom'
week 8
|
0.83 proportion of days
Standard Deviation 0.23
|
0.76 proportion of days
Standard Deviation 0.28
|
0.87 proportion of days
Standard Deviation 0.20
|
|
The Proportion of Daytimes Without 'Cardinal Symptom'
week 8(LOCF)
|
0.83 proportion of days
Standard Deviation 0.23
|
0.76 proportion of days
Standard Deviation 0.28
|
0.87 proportion of days
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 4 or 8 weekPopulation: Missing = Lafutidine(5) , Omeprazole(1)
The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain
Outcome measures
| Measure |
Lafutidine
n=139 Participants
Lafutidine 20mg/day
Lafutidine 10mg bid, po
|
Famotidine
n=145 Participants
Famotidine 40mg/day
Famotidine 20mg bid, po
|
Omeprazole
n=146 Participants
Omeprazole 20mg/day
Omeprazole 20mg qd(daily), po
|
|---|---|---|---|
|
The Proportion of Nighttimes Without 'Cardinal Symptom'
week 4
|
0.75 proportion of days
Standard Deviation 0.27
|
0.72 proportion of days
Standard Deviation 0.30
|
0.82 proportion of days
Standard Deviation 0.23
|
|
The Proportion of Nighttimes Without 'Cardinal Symptom'
week 8
|
0.87 proportion of days
Standard Deviation 0.19
|
0.78 proportion of days
Standard Deviation 0.29
|
0.89 proportion of days
Standard Deviation 0.18
|
|
The Proportion of Nighttimes Without 'Cardinal Symptom'
week 8(LOCF)
|
0.87 proportion of days
Standard Deviation 0.19
|
0.78 proportion of days
Standard Deviation 0.29
|
0.89 proportion of days
Standard Deviation 0.18
|
Adverse Events
Lafutidine
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Famotidine
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Omeprazole
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lafutidine
n=165 participants at risk
Lafutidine 20mg/day
Lafutidine 10mg bid, po
|
Famotidine
n=162 participants at risk
Famotidine 40mg/day
Famotidine 20mg bid, po
|
Omeprazole
n=167 participants at risk
Omeprazole 20mg/day
Omeprazole 20mg qd(daily), po
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
Other adverse events
| Measure |
Lafutidine
n=165 participants at risk
Lafutidine 20mg/day
Lafutidine 10mg bid, po
|
Famotidine
n=162 participants at risk
Famotidine 40mg/day
Famotidine 20mg bid, po
|
Omeprazole
n=167 participants at risk
Omeprazole 20mg/day
Omeprazole 20mg qd(daily), po
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/165 • Number of events 2 • 4 week, 8 week and 9 week
|
1.9%
3/162 • Number of events 4 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Dyspepsia
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
2.4%
4/167 • Number of events 4 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Abdominal distension
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
1.2%
2/162 • Number of events 2 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Nausea
|
1.2%
2/165 • Number of events 2 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
constipation
|
1.2%
2/165 • Number of events 2 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
1.2%
2/167 • Number of events 2 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
enteritis
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
1.2%
2/167 • Number of events 2 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Duodenitis
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Flatulence
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
4/165 • Number of events 10 • 4 week, 8 week and 9 week
|
1.2%
2/162 • Number of events 3 • 4 week, 8 week and 9 week
|
3.0%
5/167 • Number of events 5 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
2/165 • Number of events 2 • 4 week, 8 week and 9 week
|
1.2%
2/162 • Number of events 2 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Acute pyelonephritis
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Bronchopneumonia
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Cystitis
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Laryngitis
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Rhinitis
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Tinea cruris
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Nervous system disorders
Headache
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
1.9%
3/162 • Number of events 3 • 4 week, 8 week and 9 week
|
1.2%
2/167 • Number of events 2 • 4 week, 8 week and 9 week
|
|
Nervous system disorders
Dizziness
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Nervous system disorders
Somnolence
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
1.2%
2/162 • Number of events 2 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Nervous system disorders
Carotid artery stenosis
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Nervous system disorders
Migraine
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
2/165 • Number of events 2 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.61%
1/165 • Number of events 2 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.61%
1/165 • Number of events 2 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
General disorders
Fatigue
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
General disorders
Chest pain
|
1.2%
2/165 • Number of events 2 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
General disorders
Chest discomfort
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
General disorders
Sensation of foreign body
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Investigations
Alanine aminotransferase increased
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
1.2%
2/162 • Number of events 2 • 4 week, 8 week and 9 week
|
1.8%
3/167 • Number of events 3 • 4 week, 8 week and 9 week
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
1.2%
2/162 • Number of events 2 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 2 • 4 week, 8 week and 9 week
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
1.2%
2/167 • Number of events 2 • 4 week, 8 week and 9 week
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
2/165 • Number of events 2 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Psychiatric disorders
Insomnia
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Eye disorders
Dry eye
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.61%
1/165 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
|
Renal and urinary disorders
Mixed incontinence
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.00%
0/162 • 4 week, 8 week and 9 week
|
0.60%
1/167 • Number of events 1 • 4 week, 8 week and 9 week
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/165 • 4 week, 8 week and 9 week
|
0.62%
1/162 • Number of events 1 • 4 week, 8 week and 9 week
|
0.00%
0/167 • 4 week, 8 week and 9 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place