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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01673620
• Collaborator: (none)
• Enrollment: 69
• Arms: 2
• Actual Duration (Months): 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of montelukast 10 mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Montelukast 10 mg/loratadine 10 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of Combination Montelukast/Loratadine (MK-0476A) in Mexican Patients With Allergic Rhinitis
• Actual Study Start Date: Jul 4, 2012
• Actual Primary Completion Date: Oct 10, 2012
• Actual Study Completion Date: Oct 10, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Montelukast 10 mg/loratadine 10 mg Montelukast 10 mg/loratadine 10 mg combination tablet administered orally once daily for 2 weeks	Drug: Montelukast 10 mg/loratadine 10 mg; Montelukast 10 mg/loratadine 10 mg tablet administered once daily; Other Names: MK-0476A
Placebo Comparator: Placebo Matching placebo tablet administered orally once daily for 2 weeks	Drug: Placebo; Matching placebo tablet administered once daily

Outcome Measures

Primary Outcome Measures

1. Number of Participants Experiencing at Least One Adverse Event (AE) [Up to 4 weeks]

   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.

2. Number of Participants Discontinuing Study Treatment Due to AEs [Up to 2 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Not pregnant or breastfeeding and does not plan to become pregnant during the study and the 14-day follow-up period

• Female participants of reproductive potential agree to remain abstinent or use one acceptable method of birth control at least 14 days prior to signing the informed consent until 14 days following the last visit

• History for at least 2 years of seasonal allergic rhinitis symptoms that are known to flare during the local allergy season or a clinical history of at least 2 years of perennial allergic rhinitis symptoms that persist year round

• For participants with seasonal allergic rhinitis: a positive skin-prick test (wheal >= 3 mm greater than saline control) to one of the allergens active during the local allergy season or a positive radioallergosorbent test (RAST [defined as a score >= Class III])

• For participants with perennial allergic rhinitis: a positive skin test (wheal >=3 mm greater than saline control) to one of the relevant perennial allergens or a positive RAST (defined as a score >= Class III)

• Nonsmoker and has been a nonsmoker for at least 1 year prior to study Visit 1 with a smoking history of no more than 10 pack-years (1 pack [20 cigarettes] per day for 10 years)

• Must be in good and stable physical health and mental health

Exclusion Criteria:

• Hospitalization or hospitalization within 4 weeks of the first scheduled study visit

• Pregnancy or within <= 8 weeks postpartum or is breast feeding

• Any major surgical procedure within 4 weeks of the first scheduled study vist

• Current or recent past abuser of alcohol or illicit drugs

• Prior participation in a clinical trial of montelukast or loratadine within the 4 weeks prior to the first scheduled study visit

• Requires treatment other than inhaled short-acting β-agonist for asthma

(e.g., inhaled or oral corticosteroid, theophylline, nedocromil, cromolyn, oral or long-acting inhaled β-agonist, leukotriene receptor antagonist, leukotriene synthesis inhibitor) and/or uses more than 8 puffs per day of inhaled short-acting β-agonist

• Presence of an upper respiratory tract infection (URI), sinusitis, infectious rhinitis (with symptoms such as sore throat, fever, thick purulent rhinorrhea), ocular infection, or history of any of these within 4 weeks prior to the first scheduled study visit or any time between study Visits 1 and 2

• Other than asthma, any active, acute, or chronic pulmonary disorder which is documented by history or physical examination

• Rhinitis medicamentosa, or non-allergic rhinitis

• Recent history (within 3 months prior to the first scheduled study visit) of a clinically significant psychiatric disorder

• History of an anaphylactic reaction to or is otherwise hypersensitive to

montelukast, loratadine, or one of their components

• History or current evidence of any general medical condition, concomitant therapy, lab abnormality or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study

• History of illness that would require treatment with an excluded medication, could be immediately life threatening (ventricular arrhythmia, diabetes mellitus that is not well controlled), would pose restriction on participation or successful completion of the study, or would pose additional risk to the patient by administering the study drug

• History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01673620
• Other Study ID Numbers: 0476A-484
• First Posted: Aug 28, 2012
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Loratadine; Montelukast

Study Results

Participant Flow

Arm/Group Title	Montelukast 10 mg/Loratadine 10 mg	Placebo
Arm/Group Description	Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Participants receive matching placebo tablets once daily for 2 weeks
Period Title: Overall Study
STARTED	47	22
COMPLETED	46	22
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Montelukast 10 mg/Loratadine 10 mg	Placebo	Total
Arm/Group Description	Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Participants receive matching placebo tablets once daily for 2 weeks	Total of all reporting groups
Overall Participants	47	22	69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.7 (12.5)	31.9 (9.3)	30.4 (11.6)
Sex: Female, Male (Count of Participants)
Female	30 63.8%	14 63.6%	44 63.8%
Male	17 36.2%	8 36.4%	25 36.2%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Experiencing at Least One Adverse Event (AE)
Description	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.
Time Frame	Up to 4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Montelukast 10 mg/Loratadine 10 mg	Placebo
Arm/Group Description	Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Participants receive matching placebo tablets once daily for 2 weeks
Measure Participants	47	22
Number [participants]	6 12.8%	2 9.1%

2. Primary Outcome

Title	Number of Participants Discontinuing Study Treatment Due to AEs
Description	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.
Time Frame	Up to 2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Montelukast 10 mg/Loratadine 10 mg	Placebo
Arm/Group Description	Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks	Participants receive matching placebo tablets once daily for 2 weeks
Measure Participants	47	22
Number [participants]	1 2.1%	0 0%

Adverse Events

Time Frame	Up to 4 weeks
Adverse Event Reporting Description	The APaT population consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title	Montelukast 10 mg/Loratadine 10 mg		Placebo
Arm/Group Description	Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks		Participants receive matching placebo tablets once daily for 2 weeks
All Cause Mortality
	Montelukast 10 mg/Loratadine 10 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Montelukast 10 mg/Loratadine 10 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Montelukast 10 mg/Loratadine 10 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/47 (6.4%)		0/22 (0%)
Gastrointestinal disorders
Dry mouth	3/47 (6.4%)	3	0/22 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.