Rhinitis, Allergic, SeasonalPhase 3NCT00127647
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
A Phase 3 study testing montelukast sodium and Comparator: pranlukast in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
Trial summary
The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 15 to 64 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- montelukast sodium and Comparator: pranlukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,375 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Apr 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)
Who cannot join
- 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
About this study
Official title: MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis
The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- montelukast sodium, Comparator: pranlukast
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast sodiumDrug
Also called MK0476, Singulair
montelukast sodium; 5 mg, 10 mg QD 2-weeks.
Comparator: pranlukastDrug
Pranlukast 225 mg BID 2-weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | montelukast sodium 5 mg, QD 2-weeks Receives: Drug: montelukast sodium |
| 2 | Experimental | montelukast sodium 10 mg QD 2-weeks Receives: Drug: montelukast sodium |
| 3 | Active comparator | Pranlukast 225 mg BID 2-weeks Receives: Drug: Comparator: pranlukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Nasal Symptom Score
Secondary outcomes (1)
Daytime nasal symptom score, Nighttime nasal symptom score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startNov 2004
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127647
- Sponsor's protocol ID
- 0476-327
- Other IDs
- MK0476-327, 2005_038
- Status last verified
- Jan 2022
- First submitted
- 4 Aug 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00127647
- Acronym / sponsor ID
- 0476-327
- Conditions
- Rhinitis, Allergic, Seasonal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,375 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 8 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: montelukast sodiummontelukast sodium 5 mg, QD 2-weeks |
| 2 | Experimental | Drug: montelukast sodiummontelukast sodium 10 mg QD 2-weeks |
| 3 | Active comparator | Drug: Comparator: pranlukastPranlukast 225 mg BID 2-weeks |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| montelukast sodiumAlso: MK0476, Singulairmontelukast sodium; 5 mg, 10 mg QD 2-weeks. | Drug | 1, 2 |
| Comparator: pranlukastPranlukast 225 mg BID 2-weeks. | Drug | 3 |
Primary outcome
Composite Nasal Symptom Score
1 secondary outcome
Daytime nasal symptom score, Nighttime nasal symptom score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 18946234Okubo 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.
Related trials for Rhinitis, Allergic, Seasonal
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing montelukast sodium and Comparator: pranlukast in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Nasal Symptom Score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00127647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.