Trial Outcomes & Findings for A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children (NCT NCT00189462)
NCT ID: NCT00189462
Last Updated: 2020-11-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
99 participants
Primary outcome timeframe
16 weeks
Results posted on
2020-11-18
Participant Flow
Participant milestones
| Measure |
Montelukast
Treatment with montelukast for 4 months (4 mg per day)
Montelukast
|
Placebo
Treatment with placebo for 4 months
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
23
|
21
|
Reasons for withdrawal
| Measure |
Montelukast
Treatment with montelukast for 4 months (4 mg per day)
Montelukast
|
Placebo
Treatment with placebo for 4 months
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
18
|
20
|
Baseline Characteristics
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Baseline characteristics by cohort
| Measure |
Montelukast
n=50 Participants
Treatment with montelukast for 4 months (4 mg per day)
Montelukast
|
Placebo
n=49 Participants
Treatment with placebo for 4 months
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
99 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
49 participants
n=4 Participants
|
99 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 16 weeksOutcome measures
| Measure |
Montelukast
n=50 Participants
Treatment with montelukast for 4 months (4 mg per day)
Montelukast
|
Placebo
n=49 Participants
Treatment with placebo for 4 months
|
|---|---|---|
|
Incidence of Acute Otitis Media
|
30 participants with AOM
|
27 participants with AOM
|
Adverse Events
Montelukast
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Montelukast
n=50 participants at risk
Treatment with montelukast for 4 months (4 mg per day)
Montelukast
|
Placebo
n=49 participants at risk
Treatment with placebo for 4 months
|
|---|---|---|
|
General disorders
Diarrhea
|
10.0%
5/50
|
12.2%
6/49
|
|
General disorders
Vomiting
|
6.0%
3/50
|
4.1%
2/49
|
|
General disorders
Rash
|
0.00%
0/50
|
6.1%
3/49
|
|
General disorders
Cold/Upper Respiratory Infection
|
16.0%
8/50
|
8.2%
4/49
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place