BronchiolitisPhase 2NCT00394160
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
A Phase 2 study testing MK0476, Montelukast Sodium /Duration of Treatment : 14 Days in people with Bronchiolitis, run by Organon and Co.
Trial summary
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis. Read more about this study
- Who is it for?
- Ages 1 month to 3 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Oct 2005
- 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 1 month to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms.
Who cannot join
- Anemia or history of any significant illness that will pose additional risk to the patient.
About this study
Official title: A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 1 to 3 Months
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
- Medical subject headings
- Bronchiolitis
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 : 14 DaysDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.
Secondary outcomes (1)
To estimate the single-dose population pharmacokinetics, (maximum plasma concentration, time to maximum plasma concentration, and apparent half-life) of montelukast 4-mg oral granules in children aged 1 to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startDec 2004
- Primary completionOct 2005
- Study completionOct 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 BronchiolitisStudies 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
- 12 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
- NCT00394160
- Sponsor's protocol ID
- 0476-297
- Other IDs
- 2006_544
- Status last verified
- Jan 2022
- First submitted
- 27 Oct 2006
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Kearns GL, Lu S, Maganti L, Li XS, Migoya E, Ahmed T, Knorr B, Reiss TF. Pharmacokinetics and safety of montelukast oral granules in children 1 to 3 months of age with bronchiolitis. J Clin Pharmacol. 2008 Apr;48(4):502-11. doi: 10.1177/0091270008314251. Epub 2008 Feb 22.
PubMed 18296556
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 Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 1 to 3 Months
- ClinicalTrials.gov ID
- NCT00394160
- Acronym / sponsor ID
- 0476-297
- Conditions
- Bronchiolitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 31 Oct 2006 (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 study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Active bronchiolitis and a history of bronchiolitis and asthma-like symptoms.
Key exclusion criteria (1 listed)
- Anemia or history of any significant illness that will pose additional risk to the patient.
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 : 14 Days | Drug | – |
Primary outcome
To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 months.
1 secondary outcome
To estimate the single-dose population pharmacokinetics, (maximum plasma concentration, time to maximum plasma concentration, and apparent half-life) of montelukast 4-mg oral granules in children aged 1 to 3 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 18296556Kearns GL, Lu S, Maganti L, Li XS, Migoya E, Ahmed T, Knorr B, Reiss TF. Pharmacokinetics and safety of montelukast oral granules in children 1 to 3 months of age with bronchiolitis. J Clin Pharmacol. 2008 Apr;48(4):502-11. doi: 10.1177/0091270008314251. Epub 2008 Feb 22.
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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 : 14 Days in people with Bronchiolitis, 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 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?
To evaluate the safety and tolerability of montelukast oral granules in children aged 1 to 3 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 NCT00394160, 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.