Trial Outcomes & Findings for A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED) (NCT NCT00968149)
NCT ID: NCT00968149
Last Updated: 2022-02-03
Results Overview
A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
413 participants
Primary outcome timeframe
2 weeks
Results posted on
2022-02-03
Participant Flow
Thirty one study sites in the United States. Prime Therapy Period: Mar-2001 to Jun-2001.
Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis symptoms score during the run-in period were excluded from randomization.
Participant milestones
| Measure |
Montelukast 4 mg and 5 mg
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
280
|
133
|
|
Overall Study
COMPLETED
|
269
|
127
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
Montelukast 4 mg and 5 mg
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Montelukast 4 mg and 5 mg
n=280 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=133 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.9 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
8.4 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
8.0 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex/Gender, Customized
Boys
|
157 participants
n=5 Participants
|
77 participants
n=7 Participants
|
234 participants
n=5 Participants
|
|
Sex/Gender, Customized
Girls
|
123 participants
n=5 Participants
|
56 participants
n=7 Participants
|
179 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.
A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Montelukast 4 mg and 5 mg
n=280 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=133 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Number of Patients With Clinical Adverse Experiences (CAEs)
With CAEs
|
73 Participants
|
35 Participants
|
|
Number of Patients With Clinical Adverse Experiences (CAEs)
Without CAEs
|
207 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Outcome measures
| Measure |
Montelukast 4 mg and 5 mg
n=280 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=133 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Number of Patients With Serious CAEs
With Serious CAEs
|
1 Participants
|
0 Participants
|
|
Number of Patients With Serious CAEs
Without Serious CAEs
|
279 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Outcome measures
| Measure |
Montelukast 4 mg and 5 mg
n=280 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=133 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Number of Patients With Drug-related CAEs
With Drug-related CAEs
|
10 Participants
|
5 Participants
|
|
Number of Patients With Drug-related CAEs
Without Drug-related CAEs
|
270 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.
Outcome measures
| Measure |
Montelukast 4 mg and 5 mg
n=280 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=133 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to CAEs
Discontinued Due to CAEs
|
5 Participants
|
1 Participants
|
|
Number of Patients Who Were Discontinued Due to CAEs
Did Not Discontinue Due to CAEs
|
275 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Montelukast 4 mg and 5 mg
n=272 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=129 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Number of Patients With Laboratory Adverse Experiences (LAEs)
With LAEs
|
2 Participants
|
3 Participants
|
|
Number of Patients With Laboratory Adverse Experiences (LAEs)
Without LAEs
|
270 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.
Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Outcome measures
| Measure |
Montelukast 4 mg and 5 mg
n=272 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=129 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Number of Patients With Serious LAEs
With Serious LAEs
|
0 Participants
|
0 Participants
|
|
Number of Patients With Serious LAEs
Without Serious LAEs
|
272 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.
Outcome measures
| Measure |
Montelukast 4 mg and 5 mg
n=272 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=129 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Number of Patients With Drug-related LAEs
With Drug-related LAEs
|
1 Participants
|
2 Participants
|
|
Number of Patients With Drug-related LAEs
Without Drug-related LAEs
|
271 Participants
|
127 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.
Outcome measures
| Measure |
Montelukast 4 mg and 5 mg
n=272 Participants
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=129 Participants
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Number of Patients Who Were Discontinued Due to LAEs
Discontinued Due to LAEs
|
0 Participants
|
0 Participants
|
|
Number of Patients Who Were Discontinued Due to LAEs
Did Not Discontinue Due to LAEs
|
272 Participants
|
129 Participants
|
Adverse Events
Montelukast 4 mg and 5 mg
Serious events: 1 serious events
Other events: 73 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Montelukast 4 mg and 5 mg
n=280 participants at risk
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=133 participants at risk
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
Other adverse events
| Measure |
Montelukast 4 mg and 5 mg
n=280 participants at risk
Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
|
Placebo
n=133 participants at risk
Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
|
|---|---|---|
|
General disorders
Abdominal Pain
|
1.4%
4/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
1.5%
2/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Asthenia/Fatigue
|
0.71%
2/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Body Ache
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Dizziness
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Enuresis
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Facial Edema
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Fever
|
2.5%
7/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
3.0%
4/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Purulent Discharge
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Infections and infestations
Upper Respiratory Infection
|
2.1%
6/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
1.5%
2/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Infections and infestations
Viral Infection
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Infections and infestations
Viral Syndrome
|
0.71%
2/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Cardiac disorders
Ecchymosis
|
0.71%
2/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Gastrointestinal disorders
Diarrhea
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Gastrointestinal disorders
Nausea
|
1.8%
5/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
2.3%
3/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
4/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
3.8%
5/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Eye disorders
Allergic Conjunctivitis
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Eye disorders
Blepharitis
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Eye disorders
Conjunctival Edema
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Eye disorders
Conjunctival Injection
|
0.71%
2/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Vascular disorders
Epistaxis
|
1.4%
4/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
3.0%
4/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Secretion
|
0.71%
2/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Turbinate Abnormality
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Eye disorders
Ophthalmic Infection
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Otic Pain
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Ear and labyrinth disorders
Otitis
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Ear and labyrinth disorders
Otitis Externa
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Ear and labyrinth disorders
Otitis Media
|
2.1%
6/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
1.5%
2/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Pharyngitis
|
3.2%
9/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
1.5%
2/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Sinusitis
|
1.1%
3/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
General disorders
Tonsillar Disorder
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Akathisia
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Dream Abnormality
|
1.1%
3/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Head Trauma
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Headache
|
3.2%
9/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
1.5%
2/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Hyperkinesia
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Insomnia
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Sleep Disorder
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Nervous system disorders
Somnolence
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Psychiatric disorders
Behavioral Disturbance
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Psychiatric disorders
Irritability
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.1%
3/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
3/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Skin and subcutaneous tissue disorders
Eczematous Dermatitis
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Skin and subcutaneous tissue disorders
Excoriation
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Skin and subcutaneous tissue disorders
Keratosis Pilaris
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
4/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
2.3%
3/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Injury, poisoning and procedural complications
Venomous Bite/Sting
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Reproductive system and breast disorders
Menstrual Disorder
|
0.00%
0/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Renal and urinary disorders
Urinary Frequency
|
0.71%
2/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.75%
1/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Renal and urinary disorders
Urinary Urgency
|
0.36%
1/280 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/133 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.37%
1/271 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/127 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Hypercalcemia
|
0.00%
0/271 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.79%
1/127 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Hematocrit Decreased
|
0.00%
0/271 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.79%
1/127 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Hematocrit Increased
|
0.37%
1/270 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/128 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Hemoglobin Decreased
|
0.00%
0/270 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.78%
1/128 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Lymphocytes Decreased
|
0.37%
1/270 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/128 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Mean Corpuscular Volume Increased
|
0.37%
1/270 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/128 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Neutrophils Increased
|
0.37%
1/270 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.00%
0/128 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
|
Investigations
Bone Marrow Depression
|
0.00%
0/270 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
0.78%
1/128 • During the 2-week, double-blind treatment period
Patients were monitored for adverse experiences During the 2-week, double-blind treatment period; no adverse experience was suggested. Adverse experiences were recorded at each clinic visit on the Adverse Experience Case Report Forms
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER