AsthmaPhase 3NCT00700661
A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)
A Phase 3 study testing montelukast in people with Asthma, run by Organon and Co.
Trial summary
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Asthma
- What is being tested?
- montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Dec 2002
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or Female between and including the ages of 2 and 5 years
- Patient was treated with steroids for an asthma episode in the last 3 months
- Patient was admitted to the hospital or emergency room in the last 3 months
- Patient is able to chew a tablet
Who cannot join
- Patient has been in a research study in the past 4 weeks
- Patient has visited the emergency room for an asthma episode in the past week
- Patients has a history of stomach, heart, liver, nerve, kidney or blood disease
About this study
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.
- Conditions
- Asthma
- Being tested
- montelukast, placebo (unspecified)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukastDrug
Also called MK0476, SINGULAIR ®
One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks
placebo (unspecified)Drug
Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug Receives: Drug: montelukast |
| 2 | Placebo comparator | Pbo Receives: Drug: placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma episodes in 2 - 5 year old children
Measured: at 12 months
Secondary outcomes (1)
the number of treatments and duration of asthma episodes
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJan 2001
- Primary completionDec 2002
- Study completionDec 2002
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 AsthmaStudies 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
- 500 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
- NCT00700661
- Sponsor's protocol ID
- 0476-907
- Other IDs
- MK0476-907, 2007_572
- Status last verified
- Feb 2022
- First submitted
- 17 Jun 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.
PubMed 15542792
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
- A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Study to Determine the Efficacy of Montelukast in the Treatment of Exacerbations in Asthmatic Patients Aged 2-to-5 Years
- ClinicalTrials.gov ID
- NCT00700661
- Acronym / sponsor ID
- 0476-907
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 19 Jun 2008 (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.
A study to determine the efficacy of MK0476 in the Treatment of Asthmatic Patients Aged 2 to 5 Years.
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: montelukastDrug |
| 2 | Placebo comparator | Drug: placebo (unspecified)Pbo |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or Female between and including the ages of 2 and 5 years
- Patient was treated with steroids for an asthma episode in the last 3 months
- Patient was admitted to the hospital or emergency room in the last 3 months
- Patient is able to chew a tablet
Key exclusion criteria (3 listed)
- Patient has been in a research study in the past 4 weeks
- Patient has visited the emergency room for an asthma episode in the past week
- Patients has a history of stomach, heart, liver, nerve, kidney or blood 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 |
|---|---|---|
| montelukastAlso: MK0476, SINGULAIR ®One montelukast 4-mg chewable tablet (CT) administered once daily at bedtime. Duration of Treatment: 48 Weeks | Drug | 1 |
| placebo (unspecified)Matching-image Montelukast placebo. Duration of Treatment: 48 Weeks | Drug | 2 |
Primary outcome
asthma episodes in 2 - 5 year old children
Time frame: at 12 months
1 secondary outcome
the number of treatments and duration of asthma episodes
Time frame: at 12 months
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.
- Background: PubMed 15542792Bisgaard H, Zielen S, Garcia-Garcia ML, Johnston SL, Gilles L, Menten J, Tozzi CA, Polos P. Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma. Am J Respir Crit Care Med. 2005 Feb 15;171(4):315-22. doi: 10.1164/rccm.200407-894OC. Epub 2004 Nov 12.
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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 in people with Asthma, 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 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. 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?
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?
asthma episodes in 2 - 5 year old children (time frame: at 12 months). 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 NCT00700661, 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.