A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

NCT00960141 | Completed Phase 3 Results

• 3 other identifiers: 0476-192MK0476-1922009_633
• Study Type: interventional
• Target: 829
• Locations: 0 countries
• Sites: N/A

Brief Summary

A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Daytime Nasal Symptoms Score

  Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.

  Baseline and Week 2

Secondary Outcomes (5)

• Mean Change From Baseline in Nighttime Symptoms Score

  Baseline and Week 2

• Mean Change From Baseline in Daytime Eye Symptoms Score

  Baseline and Week 2

• Patient's Global Evaluation of Allergic Rhinitis

  Week 2 (or upon discontinuation)

• Physician's Global Evaluation of Allergic Rhinitis

  Week 2

• Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score

  Baseline and Week 2

Study Arms (3)

1

EXPERIMENTAL

montelukast

Drug: montelukast sodium

2

ACTIVE COMPARATOR

loratadine

Drug: Comparator: loratadine

3

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

Interventions

montelukast sodium DRUG

montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks

1

Comparator: loratadine DRUG

loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks

2

Comparator: placebo DRUG

placebo tablet, taken orally once daily at bed time for 2 weeks

3

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
• Patient is a non-smoker
• Patient is in good mental and physical health

You may not qualify if:

• Patient is hospitalized
• Patient is a woman who is \<8 weeks postpartum or is breast feeding
• Patient intends to move or vacation away during the study
• Patient is a current or past abuser of alcohol or illicit drugs

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73. doi: 10.1016/S1081-1206(10)61576-1.

  PMID: 15049402 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: August 1, 2000
• Primary Completion: October 1, 2000
• Study Completion: November 1, 2000
• Last Updated: February 3, 2022
• Results First Posted: June 9, 2010

Record last verified: 2022-02