Trial Outcomes & Findings for A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children (NCT NCT01458418)
NCT ID: NCT01458418
Last Updated: 2020-10-30
Results Overview
Eosinophils/high powered field(hpf) in the mid esophagus will be measured after 12 weeks of therapy.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-10-30
Participant Flow
Enrollment took place between 9/17/2012 and 1/7/2013 in a clinical setting.
There were no pre-assignment details. All inclusion/exclusion criteria were measured using existing, standard of care data. All subjects who signed informed consent were randomized (although it is not now know which arm they were randomized to as no unblinding was ever done due to low enrollment and lack of data).
Participant milestones
| Measure |
Montelukast 10 mg/Day
Subjects will receive two 5mg tablets of Montelukast/day.
Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.
|
Montelukast 5mg/Day
Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.
5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.
|
Placebo
Subjects will receive two placebo tablets per day.
placebo: Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day.
|
Subjects Who Were Not Unblinded so Arm is Unknown
Subjects were never unblinded and no results were reported due to small number of enrolled subjects and lack of amount of data to show any demonstrable differences.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children
Baseline characteristics by cohort
| Measure |
Montelukast 10 mg/Day
Subjects will receive two 5mg tablets of Montelukast/day.
Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.
|
Montelukast 5mg/Day
Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.
5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.
|
Placebo
Subjects will receive two placebo tablets per day.
placebo: Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day.
|
Subjects Who Were Not Unblinded so Arm is Unknown
n=4 Participants
Subjects were never unblinded and no results were reported due to small number of enrolled subjects and lack of amount of data to show any demonstrable differences.
|
Total
n=4 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
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
—
|
—
|
—
|
10 years
n=4 Participants
|
10 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
—
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Subjects were not unblinded due to inability to enroll numbers to create generalizable knowledge, so we don't know how many subjects were in each arm.
Eosinophils/high powered field(hpf) in the mid esophagus will be measured after 12 weeks of therapy.
Outcome measures
| Measure |
Montelukast 10 mg/Day
Subjects will receive two 5mg tablets of Montelukast/day.
Montelukast: Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.
|
Montelukast 5mg/Day
Subjects will receive one 5mg tablet of montelukast and 1 placebo tablet per day.
5 mg Montelukast: Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.
|
Placebo
Subjects will receive two placebo tablets per day.
placebo: Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day.
|
Subjects Whose Arm is Unknown Due to Not Being Unblinded
n=4 Participants
subjects were never unblinded as data was never analyzed due to too few subjects to create generalizable knowledge.
|
|---|---|---|---|---|
|
Eosinophil Count
|
—
|
—
|
—
|
8 Eosinophils/HPF
Interval 2.0 to 20.0
|
Adverse Events
Montelukast 10 mg/Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Montelukast 5mg/Day
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjects Who Were Not Unblinded so Arm is Unknown
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place