NCT00127647

Brief Summary

The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,375

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
Last Updated

August 15, 2024

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

August 4, 2005

Last Update Submit

August 12, 2024

Conditions

Rhinitis, Allergic, Seasonal

Outcome Measures

Primary Outcomes (1)

  • Composite Nasal Symptom Score

Secondary Outcomes (1)

  • Daytime nasal symptom score, Nighttime nasal symptom score

Study Arms (3)

1

EXPERIMENTAL

montelukast sodium 5 mg, QD 2-weeks

Drug: montelukast sodium

2

EXPERIMENTAL

montelukast sodium 10 mg QD 2-weeks

Drug: montelukast sodium

3

ACTIVE COMPARATOR

Pranlukast 225 mg BID 2-weeks

Drug: Comparator: pranlukast

Interventions

montelukast sodiumDRUG

montelukast sodium; 5 mg, 10 mg QD 2-weeks.

Also known as: MK0476, Singulair
12
Comparator: pranlukastDRUG

Pranlukast 225 mg BID 2-weeks.

3

Eligibility Criteria

Age15 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)

You may not qualify if:

  • Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Okubo K, Baba K. A double-blind non-inferiority clinical study of montelukast, a cysteinyl leukotriene receptor 1 antagonist, compared with pranlukast in patients with seasonal allergic rhinitis. Allergol Int. 2008 Dec;57(4):383-90. doi: 10.2332/allergolint.O-08-533. Epub 2008 Nov 1.

    PMID: 18946234RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

montelukast

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

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 4, 2005

First Posted

August 8, 2005

Study Start

November 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

August 15, 2024

Record last verified: 2022-01