Seasonal Allergic RhinitisPhase 3NCT00968149
A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED)
A Phase 3 study testing montelukast sodium in people with Seasonal Allergic Rhinitis, run by Organon and Co.
Trial summary
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season. Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- montelukast sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 413 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Jul 2001
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient has a history of allergic rhinitis symptoms which flare up during the study season
- Patient is a non-smoker
- Patient is in otherwise good health
- Patient is able to chew a tablet
Who cannot join
- Patient is hospitalized
- Patient is pregnant or nursing mother, or <8 weeks post partum
- Patient and/or parent intend to move or vacation away from home during the trial
- Patient has had a major surgical procedure within 4 weeks of the prestudy visit
- Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
- Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study
- Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- montelukast sodium, Comparator: Placebo
- 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
one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years
Comparator: PlaceboDrug
one placebo chewable tablet daily at bed time for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Montelukast Receives: Drug: montelukast sodium |
| 2 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Clinical Adverse Experiences (CAEs)
A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Measured: 2 weeks
Secondary outcomes (7)
Number of Patients With Serious CAEs
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Measured: 2 weeks
Number of Patients With Drug-related CAEs
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Measured: 2 weeks
Number of Patients Who Were Discontinued Due to CAEs
Measured: 2 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs)
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Measured: 2 weeks
Number of Patients With Serious LAEs
Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Measured: 2 weeks
Number of Patients With Drug-related LAEs
Measured: 2 weeks
Number of Patients Who Were Discontinued Due to LAEs
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startMar 2001
- Primary completionJun 2001
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies 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
- 413 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
- NCT00968149
- Sponsor's protocol ID
- 0476-219
- Other IDs
- MK0476-219, 2009_652
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2009
- Last updated
- 3 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018.
PubMed 19449366
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Age 2 Through 14 Years With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00968149
- Acronym / sponsor ID
- 0476-219
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 11 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: montelukast sodiumMontelukast |
| 2 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient has a history of allergic rhinitis symptoms which flare up during the study season
- Patient is a non-smoker
- Patient is in otherwise good health
- Patient is able to chew a tablet
Key exclusion criteria (7 listed)
- Patient is hospitalized
- Patient is pregnant or nursing mother, or <8 weeks post partum
- Patient and/or parent intend to move or vacation away from home during the trial
- Patient has had a major surgical procedure within 4 weeks of the prestudy visit
- Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study
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 sodiumone montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years | Drug | 1 |
| Comparator: Placeboone placebo chewable tablet daily at bed time for 2 weeks | Drug | 2 |
Primary outcome
Number of Patients With Clinical Adverse Experiences (CAEs)
Time frame: 2 weeks
A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
7 secondary outcomes
Number of Patients With Serious CAEs
Time frame: 2 weeks
Number of Patients With Drug-related CAEs
Time frame: 2 weeks
Number of Patients Who Were Discontinued Due to CAEs
Time frame: 2 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs)
Time frame: 2 weeks
Number of Patients With Serious LAEs
Time frame: 2 weeks
Number of Patients With Drug-related LAEs
Time frame: 2 weeks
Number of Patients Who Were Discontinued Due to LAEs
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19449366Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018.
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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 3 study testing montelukast sodium in people with Seasonal Allergic Rhinitis, 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 4 inclusion and 7 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 3 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Clinical Adverse Experiences (CAEs) (time frame: 2 weeks). 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 NCT00968149, 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 3 Feb 2022.