Trial Outcomes & Findings for A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484) (NCT NCT01673620)

Results Overview

An 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 study treatment, whether or not considered related to the use of the study treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

69 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2024-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Montelukast 10 mg/Loratadine 10 mg Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Placebo Participants receive matching placebo tablets once daily for 2 weeks
Overall Study STARTED	47	22
Overall Study COMPLETED	46	22
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Montelukast 10 mg/Loratadine 10 mg Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Placebo Participants receive matching placebo tablets once daily for 2 weeks
Overall Study Adverse Event	1	0

Baseline Characteristics

A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Montelukast 10 mg/Loratadine 10 mg n=47 Participants Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Placebo n=22 Participants Participants receive matching placebo tablets once daily for 2 weeks	Total n=69 Participants Total of all reporting groups
Age, Continuous	29.7 years STANDARD_DEVIATION 12.5 • n=5 Participants	31.9 years STANDARD_DEVIATION 9.3 • n=7 Participants	30.4 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	14 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 weeks

Population: The All-Patients-as-Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.

An 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 study treatment, whether or not considered related to the use of the study treatment.

Outcome measures

Outcome measures
Measure	Montelukast 10 mg/Loratadine 10 mg n=47 Participants Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Placebo n=22 Participants Participants receive matching placebo tablets once daily for 2 weeks
Number of Participants Experiencing at Least One Adverse Event (AE)	6 participants	2 participants

PRIMARY outcome

Timeframe: Up to 2 weeks

Population: The APaT population consisted of all randomized participants who received at least one dose of study drug.

An 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 study treatment, whether or not considered related to the use of the study treatment.

Outcome measures

Outcome measures
Measure	Montelukast 10 mg/Loratadine 10 mg n=47 Participants Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Placebo n=22 Participants Participants receive matching placebo tablets once daily for 2 weeks
Number of Participants Discontinuing Study Treatment Due to AEs	1 participants	0 participants

Adverse Events

Montelukast 10 mg/Loratadine 10 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Montelukast 10 mg/Loratadine 10 mg n=47 participants at risk Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Placebo n=22 participants at risk Participants receive matching placebo tablets once daily for 2 weeks
Gastrointestinal disorders Dry mouth	6.4% 3/47 • Number of events 3 • Up to 4 weeks The APaT population consisted of all randomized participants who received at least one dose of study drug.	0.00% 0/22 • Up to 4 weeks The APaT population consisted of all randomized participants who received at least one dose of study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER