Rhinitis AllergicPhase 2NCT00446186
MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)
A Phase 2 study testing MK0476, montelukast sodium / Duration of Treatment: 2 Weeks in people with Rhinitis Allergic, run by Organon and Co.
Trial summary
The clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Rhinitis Allergic
- What is being tested?
- MK0476, montelukast sodium / Duration of Treatment: 2 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 945 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Mar 2004
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with seasonal allergic rhinitis
Who cannot join
- Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness
- Patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis)
- Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease
About this study
Official title: Mk0476 Phase II Dose Finding Study -Allergic Rhinitis-
The clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis.
- Conditions
- Rhinitis Allergic
- Being tested
- MK0476, montelukast sodium / Duration of Treatment: 2 Weeks, Comparator: placebo / Duration of Treatment: 2 Weeks
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0476, montelukast sodium / Duration of Treatment: 2 WeeksDrug
Comparator: placebo / Duration of Treatment: 2 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2007 (estimated)
- Study startFeb 2004
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rhinitis AllergicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 945 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
- NCT00446186
- Sponsor's protocol ID
- 0476-378
- Other IDs
- 2007_009
- Status last verified
- Jan 2022
- First submitted
- 9 Mar 2007
- 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 18946234Okubo K, Baba K. Therapeutic effect of montelukast, a cysteinyl leukotriene receptor 1 antagonist, on Japanese patients with seasonal allergic rhinitis. Allergol Int. 2008 Sep;57(3):247-55. doi: 10.2332/allergolint.O-07-515. Epub 2008 Jul 1.
PubMed 18566548
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 II Dose Finding Study -Allergic Rhinitis-
- ClinicalTrials.gov ID
- NCT00446186
- Acronym / sponsor ID
- 0476-378
- Conditions
- Rhinitis Allergic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 945 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 12 Mar 2007 (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 clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with seasonal allergic rhinitis
Key exclusion criteria (3 listed)
- Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection and those disease severe enough to interfere with assessment of effectiveness
- Patients who have rhinitis medicamentosa, or nonallergic rhinitis (e.g., vasomotor rhinitis, eosinophilia rhinitis)
- Patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease
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 |
|---|---|---|
| MK0476, montelukast sodium / Duration of Treatment: 2 Weeks | Drug | – |
| Comparator: placebo / Duration of Treatment: 2 Weeks | Drug | – |
Primary outcome
The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis
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.
- Results publication: PubMed 18566548Okubo K, Baba K. Therapeutic effect of montelukast, a cysteinyl leukotriene receptor 1 antagonist, on Japanese patients with seasonal allergic rhinitis. Allergol Int. 2008 Sep;57(3):247-55. doi: 10.2332/allergolint.O-07-515. Epub 2008 Jul 1.
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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 2 study testing MK0476, montelukast sodium / Duration of Treatment: 2 Weeks in people with Rhinitis Allergic, 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 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis. 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 NCT00446186, which also lists 2 linked publications.
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.