AsthmaPhase 3NCT00968201
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
A Phase 3 study testing montelukast sodium in people with Asthma, run by Organon and Co.
Trial summary
A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time. 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 sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 689 participants
- Where
- No sites listed yet
- Study dates
- Dec 1997to Mar 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 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient has history of physician diagnosed asthma
- Patient is in otherwise good stable health
- Patient is able to chew a tablet
Who cannot join
- Patient is hospitalized
- Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
- Patient had any major surgical procedure within 4 weeks before the study
- Patient had active sinus disease within 3 weeks before the study
- Patient had required intubation for asthma in the past
- Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
- Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients
A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.
- Conditions
- Asthma
- Being tested
- montelukast sodium, Comparator: Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast sodiumDrug
one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks
Comparator: PlaceboDrug
one chewable placebo tablet, once daily at bedtime for 12 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 (CAE) Reported by Patients - Base Study
An 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: 12 weeks of treatment
Secondary outcomes (26)
Number of Patients With Drug-related CAEs Reported by Patients - Base Study
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Measured: 12 weeks of treatment
Number of Patients With Serious CAEs Reported by Patients - Base Study
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: 12 weeks of treatment
Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
Patients who reported serious drug-related CAEs during 12 weeks of treatment
Measured: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to CAEs - Base Study
Patients who were discontinued due to CAEs during 12 weeks of treatment
Measured: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment
Measured: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
Patients who were discontinued due to serious CAEs during 12 weeks of treatment
Measured: 12 weeks of treatment
Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
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: 12 weeks of treatment
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Measured: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to LAEs - Base Study
Patients who were discontinued due to LAEs during 12 weeks of treatment
Measured: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment
Measured: 12 weeks of treatment
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
An 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: up to 2.8 years
Number of Patients With Drug-related CAEs Reported by Patients - Extension
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Measured: up to 2.8 years
Number of Patients With Serious CAEs Reported by Patients - Extension
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: up to 2.8 years
Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
Patients who reported serious drug-related CAEs up to 2.8 years of
treatment
Measured: up to 2.8 years
Number of Patients Who Were Discontinued Due to CAEs - Extension
Patients who were discontinued due to CAEs up to 2.8 years of treatment
Measured: up to 2.8 years
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment
Measured: up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment
Measured: up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment
Measured: up to 2.8 years
Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
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: up to 2.8 years
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Measured: up to 2.8 years
Number of Patients With Serious LAEs - Extension
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: up to 2.8 years
Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
Patients who reported serious drug-related LAEs up to 2.8 years of treatment
Measured: up to 2.8 years
Number of Patients Who Were Discontinued Due to LAEs - Extension
Patients who were discontinued due to LAEs up to 2.8 years of treatment
Measured: up to 2.8 years
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment
Measured: up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment
Measured: up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment
Measured: up to 2.8 years
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 startDec 1997
- Primary completionMar 2001
- Study completionMar 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 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
- 689 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
- NCT00968201
- Sponsor's protocol ID
- 0476-072
- Other IDs
- 2009_651
- 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
Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, Michele TM, Reiss TF, Nguyen HH, Bratton DL. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics. 2001 Sep;108(3):E48. doi: 10.1542/peds.108.3.e48.
PubMed 11533366
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 Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients
- ClinicalTrials.gov ID
- NCT00968201
- Acronym / sponsor ID
- 0476-072
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 1997
- Primary completion
- Mar 2001 (actual)
- Study completion
- Mar 2001 (actual)
- First posted
- 28 Aug 2009 (estimated)
- Results
- Posted 3 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.
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 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient has history of physician diagnosed asthma
- Patient is in otherwise good stable health
- Patient is able to chew a tablet
Key exclusion criteria (7 listed)
- Patient is hospitalized
- Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
- Patient had any major surgical procedure within 4 weeks before the study
- Patient had active sinus disease within 3 weeks before the study
- Patient had required intubation for asthma in the past
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 chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks | Drug | 1 |
| Comparator: Placeboone chewable placebo tablet, once daily at bedtime for 12 weeks | Drug | 2 |
Primary outcome
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
Time frame: 12 weeks of treatment
An 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
26 secondary outcomes
Number of Patients With Drug-related CAEs Reported by Patients - Base Study
Time frame: 12 weeks of treatment
Number of Patients With Serious CAEs Reported by Patients - Base Study
Time frame: 12 weeks of treatment
Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
Time frame: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to CAEs - Base Study
Time frame: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
Time frame: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
Time frame: 12 weeks of treatment
Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
Time frame: 12 weeks of treatment
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
Time frame: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to LAEs - Base Study
Time frame: 12 weeks of treatment
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
Time frame: 12 weeks of treatment
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
Time frame: up to 2.8 years
Number of Patients With Drug-related CAEs Reported by Patients - Extension
Time frame: up to 2.8 years
Number of Patients With Serious CAEs Reported by Patients - Extension
Time frame: up to 2.8 years
Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
Time frame: up to 2.8 years
Number of Patients Who Were Discontinued Due to CAEs - Extension
Time frame: up to 2.8 years
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
Time frame: up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
Time frame: up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
Time frame: up to 2.8 years
Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
Time frame: up to 2.8 years
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
Time frame: up to 2.8 years
Number of Patients With Serious LAEs - Extension
Time frame: up to 2.8 years
Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
Time frame: up to 2.8 years
Number of Patients Who Were Discontinued Due to LAEs - Extension
Time frame: up to 2.8 years
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
Time frame: up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
Time frame: up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
Time frame: up to 2.8 years
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 11533366Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, Michele TM, Reiss TF, Nguyen HH, Bratton DL. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics. 2001 Sep;108(3):E48. doi: 10.1542/peds.108.3.e48.
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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 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 3 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 3 Aug 2010). 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 (CAE) Reported by Patients - Base Study (time frame: 12 weeks of treatment). 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 NCT00968201, 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.