Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

NCT00974571 | Completed Phase 3 Results

• 3 other identifiers: 0476-246MK0476-2462009_659
• Study Type: interventional
• Target: 1,365
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

Conditions

Perennial 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. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale \[Score 0 (best) to 3 (worst)\]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.

  Baseline and first 4 weeks of a 6-week treatment period

Secondary Outcomes (4)

• Mean Change From Baseline in Nighttime Symptoms Score

  Baseline and first 4 weeks in 6-week treatment period

• Mean Change From Baseline in Composite Symptoms Score

  Baseline and first 4 weeks in 6-week treatment period

• Patient's Global Evaluation of Allergic Rhinitis

  End of the first 4 weeks in 6-week treatment period

• Physician's Global Evaluation of Allergic Rhinitis

  End of the first 4 weeks in 6-week treatment period

Study Arms (3)

1

EXPERIMENTAL

montelukast

Drug: montelukast sodium

2

ACTIVE COMPARATOR

cetirizine

Drug: Comparator: cetirizine

3

PLACEBO COMPARATOR

placebo

Drug: Comparator: placebo

Interventions

montelukast sodium DRUG

montelukast 10 mg tablet orally once daily at bedtime for 6 weeks

1

Comparator: cetirizine DRUG

cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks

2

Comparator: placebo DRUG

placebo tablet orally once daily at bedtime for 6 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 perennial allergic rhinitis
• Patient is a nonsmoker
• Patient is in good general health

You may not qualify if:

• Patient is hospitalized
• Patient is a woman who is \<8 weeks postpartum or is breast-feeding
• Patient is a current or past abuser of alcohol or illicit drugs

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, Tozzi CA, Dass SB, Reiss TF. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc. 2007 May-Jun;28(3):296-304. doi: 10.2500/aap.2007.28.3000.

  PMID: 17619558 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

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.

ClinicalTrialsDisclosure@merck.com

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: September 9, 2009
• First Posted: September 10, 2009
• Study Start: November 1, 2001
• Primary Completion: May 1, 2002
• Study Completion: May 1, 2002
• Last Updated: February 3, 2022
• Results First Posted: June 7, 2010

Record last verified: 2022-02