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CompletedNCT00127647Updated Aug 15, 2024

An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

A Phase 3 interventional study of montelukast sodium and Comparator: pranlukast in Rhinitis, Allergic, Seasonal, sponsored by Organon and Co. Completed. Open to participants aged 15 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,375
Allocation
Randomized
Ages
15 Years to 64 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Rhinitis, Allergic, Seasonal
03

In context

Rhinitis, Allergic, Seasonal

396 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.

This study's enrollment of 1,375 is above the median of 136 across 360 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,375 participants (actual)

Study arms

  • Experimental
    1

    montelukast sodium 5 mg, QD 2-weeks

    Drug: montelukast sodium

  • Experimental
    2

    montelukast sodium 10 mg QD 2-weeks

    Drug: montelukast sodium

  • Active comparator
    3

    Pranlukast 225 mg BID 2-weeks

    Drug: Comparator: pranlukast

Interventions

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

    Also known as: MK0476, Singulair

  • DrugComparator: pranlukast

    Pranlukast 225 mg BID 2-weeks.

06

What researchers measure

Primary outcomes

  1. Composite Nasal Symptom Score

Secondary outcomes

  1. Daytime nasal symptom score, Nighttime nasal symptom score

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18946234 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00127647
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Aug 8, 2005
Start date
Nov 2004
Primary completion
Apr 2005
Completion
Apr 2005
Last update
Aug 15, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Montelukast

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