Nasal ObstructionPhase 4NCT00553891
Placebo-controlled Trial With Nasonex for Nasal Obstruction Secondary to Adenoids Hypertrophy in Children (P04367)(TERMINATED)
A Phase 4 study testing mometasone furoate nasal spray in people with Nasal Obstruction and Adenoids Hypertrophy, run by Organon and Co.
Trial summary
This is a randomized, double-blind, placebo-controlled study to document the long-term effect of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy as reflected by the need for removal of the adenoids within one year of the treatment regimen. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Nasal Obstruction, Adenoids Hypertrophy, Adenoidectomy
- What is being tested?
- mometasone furoate nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Oct 2009
- Phase
- Phase 4
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Should be between 2 and 11 years.
- Should have nasal obstruction for at least 3 months.
- Should have evidence of adenoids hypertrophy by nasopharyngoscopy, which cause >50% obstruction of the posterior choanae.
- May have concomitant allergic rhinitis, by history, \& and specific blood studies; however, the symptoms should be under control during the study period.
Who cannot join
- Patients with less than 50% obstruction of the post choanae.
- Patients with history of recurrent epistaxis or immunodeficiency.
- Patients with severe septal deviation.
- Patients with unilateral or bilateral choanal atresia, large nasal polyps or any nasal mass.
- Known allergy to the drug.
- Presence of chronic otitis media defined as: otorreha + perforation (concomitant otitis media with effusion, or recurrent otitis media are not excluded).
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- Cystic fibrosis \& other causes responsible for nasal obstruction.
- Infection (ie; sinusitis).
- History of recent surgery or trauma to nose, unless all wounds have healed.
About this study
Official title: Double Blind, Placebo Controlled Trial, Evaluating the Role of Nasonex® in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
This is a randomized, double-blind, placebo-controlled study to document the long-term effect of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy as reflected by the need for removal of the adenoids within one year of the treatment regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will be followed starting first dose-till 30 days after study treatment period completion.
This study was terminated - Please see "P04367 - Lebanon"
- Conditions
- Nasal Obstruction, Adenoids Hypertrophy, Adenoidectomy
- Being tested
- mometasone furoate nasal spray, placebo nasal spray
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoate nasal sprayDrug
Also called SCH 32088, Nasonex
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months.
placebo nasal sprayDrug
One spray in each nostril once daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Nasonex Nasal Spray | Experimental | Not described Receives: Drug: mometasone furoate nasal spray |
| Placebo Nasal Spray | Placebo comparator | Not described Receives: Drug: placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the long-term effect of treatment with Nasonex in moderate to severe adenoids hypertrophy (which cause >50% obstruction of the posterior choanae). as reflected by the need for adenoidectomy within one year of the treatment regimen.
Measured: The total duration of therapy is 3 months the follow up period is for 12 months.
Secondary outcomes (1)
To identify the characteristics of subjects who will show complete or significant resolution of the nasal obstruction symptoms secondary to enlarged adenoids, upon using Nasonex.
Measured: The total duration of therapy is 3 months the follow up period is for 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startMay 2006
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: No enrollment because of war in the study country.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553891
- Sponsor's protocol ID
- P04367
- Status last verified
- Feb 2022
- First submitted
- 5 Nov 2007
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Placebo Controlled Trial, Evaluating the Role of Nasonex® in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
- ClinicalTrials.gov ID
- NCT00553891
- Acronym / sponsor ID
- P04367
- Conditions
- Nasal Obstruction, Adenoids Hypertrophy, Adenoidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment because of war in the study country.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Nov 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.
This is a randomized, double-blind, placebo-controlled study to document the long-term effect of treatment with mometasone furoate nasal spray in moderate to severe adenoids hypertrophy as reflected by the need for removal of the adenoids within one year of the treatment regimen. Subjects will be assigned treated with either mometasone furoate nasal spray or placebo for 3 months. Subjects will be followed for an addition 12 months. Serious AEs will be followed starting first dose-till 30 days after study treatment period completion.
This study was terminated - Please see "P04367 - Lebanon"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasonex Nasal Spray | Experimental | Drug: mometasone furoate nasal spray |
| Placebo Nasal Spray | Placebo comparator | Drug: placebo nasal spray |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Should be between 2 and 11 years.
- Should have nasal obstruction for at least 3 months.
- Should have evidence of adenoids hypertrophy by nasopharyngoscopy, which cause >50% obstruction of the posterior choanae.
- May have concomitant allergic rhinitis, by history, \& and specific blood studies; however, the symptoms should be under control during the study period.
Key exclusion criteria (9 listed)
- Patients with less than 50% obstruction of the post choanae.
- Patients with history of recurrent epistaxis or immunodeficiency.
- Patients with severe septal deviation.
- Patients with unilateral or bilateral choanal atresia, large nasal polyps or any nasal mass.
- Known allergy to the drug.
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 |
|---|---|---|
| mometasone furoate nasal sprayAlso: SCH 32088, NasonexOne spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months. | Drug | Nasonex Nasal Spray |
| placebo nasal sprayOne spray in each nostril once daily for 3 months. | Drug | Placebo Nasal Spray |
Primary outcome
To document the long-term effect of treatment with Nasonex in moderate to severe adenoids hypertrophy (which cause >50% obstruction of the posterior choanae). as reflected by the need for adenoidectomy within one year of the treatment regimen.
Time frame: The total duration of therapy is 3 months the follow up period is for 12 months.
1 secondary outcome
To identify the characteristics of subjects who will show complete or significant resolution of the nasal obstruction symptoms secondary to enlarged adenoids, upon using Nasonex.
Time frame: The total duration of therapy is 3 months the follow up period is for 12 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mometasone furoate nasal spray in people with Nasal Obstruction and Adenoids Hypertrophy, 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 9 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: withdrawn, as of the sponsor's last update on 18 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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 document the long-term effect of treatment with Nasonex in moderate to severe adenoids hypertrophy (which cause >50% obstruction of the posterior choanae). as reflected by the need for adenoidectomy within one year of the treatment regimen. (time frame: The total duration of therapy is 3 months the follow up period is for 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2022.