Rhinitis, Allergic, PerennialPhase 3NCT00779740
Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray (Study P04419)
A Phase 3 study testing mometasone furoate in people with Rhinitis, Allergic, Perennial, run by Organon and Co.
Trial summary
This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- mometasone furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2005to 1 Apr 2005
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of mongoloid race residing in Japan who satisfy all of the following criteria:
- Patients having symptoms of perennial allergic rhinitis of moderate or severe degree, according to the classification of severity in the guidelines for the treatment of nasal allergy (partial revision) as well as a score of at least 4 in the score of 4 nasal symptoms, at the time of obtaining informed consent and during the pretreatment observation period.
- Patients with a positive skin reaction test or specific IgE antibody quantitation, and with a positive cytological examination of nasal discharge (eosinophils) or nasal challenge test.
- Outpatients who are at least 16 years of age at the time of informed consent obtained.
- Male or female.
- Patients who have the ability to give written informed consent (informed consent of the guardian must also be obtained for patients younger than 20 years).
- Patients who can keep nasal allergy diary without fail.
Who cannot join
- Patients with coexisting tuberculous disease or lower respiratory tract infection, or patients who, at the time of registration, have acute upper respiratory tract infection, acute pharyngitis, acute amygdalitis etc.
- Patients with coexisting infections or systemic mycosis for which there are no effective antibiotics.
- Patients with unhealed nasal septum ulcers, nasal surgery scar, or nasal trauma.
- Patients with a history of hypersensitivity to steroids or mometasone furoate.
- Patients who are pregnant or nursing or who may be pregnant and patients or patients' partners who desire to become pregnant during the study period.
- Patients with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension or other serious coexisting diseases and whose general condition is poor.
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- Patients also allergic to pollen and the pollen release season occurs during the study period.
- Patients with vasomotor rhinitis or eosinophilic rhinitis.
- Patients with a nasal condition which may interfere with efficacy evaluation of the investigational product.
- Patients who develop disease affecting nasal symptoms during the pretreatment observation period, i.e., during the 7 days before actual registration.
- Patients who are participating or have participated in a clinical trial of another investigational drug within 120 days (4 months) before the day of the informed consent for this study.
- Patients for whom the period of discontinuation of previous treatment effective for allergic rhinitis before the start of the investigational product administration is not sufficient or who cannot avoid its use.
- Patients receiving specific desensitization therapy or nonspecific modulation therapy or who had just discontinued such therapies within 90 days (3 months) before providing consent to this study (unless such therapies are ongoing as maintenance therapy and had been started 180 days [6 months] or more before consent to this study).
- Other patients judged inappropriate for study by the investigator or subinvestigator.
About this study
Official title: Clinical Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray
This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- mometasone furoate
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoateDrug
Also called Nasonex, SCH 32088
The dose will be 50 mcg as MF in one spray (100 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.
mometasone furoateDrug
Also called Nasonex, SCH 32088
The dose will be 50 mcg as MF in one spray (50 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.
| Study group | Role | What they receive |
|---|---|---|
| New Formulation Group | Experimental | Not described Receives: Drug: mometasone furoate |
| Old Formulation Group | Active comparator | Not described Receives: Drug: mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2.
Measured: After 2 weeks of treatment
Secondary outcomes (4)
Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching).
Measured: After 2 weeks of treatment
Overall improvement
Measured: 2 weeks
Adverse events
Measured: From initial day of treatment until treatment is stopped.
Laboratory tests
Measured: At 7 or more days before treatment start, and after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study start1 Feb 2005
- Primary completion1 Apr 2005
- Study completion1 Apr 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 Rhinitis, Allergic, PerennialStudies 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
- None (open label)
- Enrolment
- 102 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
- NCT00779740
- Sponsor's protocol ID
- P04419
- Other IDs
- JPC-04-342-41
- Status last verified
- Feb 2022
- First submitted
- 23 Oct 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
T. Ishikawa et. al; Practica otologica. Suppl.123 Page1-18 (2008.12) -Japanese language journal
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
- Clinical Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray
- ClinicalTrials.gov ID
- NCT00779740
- Acronym / sponsor ID
- P04419
- Conditions
- Rhinitis, Allergic, Perennial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2005 (actual)
- Primary completion
- 1 Apr 2005 (actual)
- Study completion
- 1 Apr 2005 (actual)
- First posted
- 24 Oct 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.
This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Formulation Group | Experimental | Drug: mometasone furoate |
| Old Formulation Group | Active comparator | Drug: mometasone furoate |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of mongoloid race residing in Japan who satisfy all of the following criteria:
Key exclusion criteria (14 listed)
- Patients with coexisting tuberculous disease or lower respiratory tract infection, or patients who, at the time of registration, have acute upper respiratory tract infection, acute pharyngitis, acute amygdalitis etc.
- Patients with coexisting infections or systemic mycosis for which there are no effective antibiotics.
- Patients with unhealed nasal septum ulcers, nasal surgery scar, or nasal trauma.
- Patients with a history of hypersensitivity to steroids or mometasone furoate.
- Patients who are pregnant or nursing or who may be pregnant and patients or patients' partners who desire to become pregnant during the study period.
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 furoateAlso: Nasonex, SCH 32088The dose will be 50 mcg as MF in one spray (100 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg. | Drug | New Formulation Group |
| mometasone furoateAlso: Nasonex, SCH 32088The dose will be 50 mcg as MF in one spray (50 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg. | Drug | Old Formulation Group |
Primary outcome
Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2.
Time frame: After 2 weeks of treatment
4 secondary outcomes
Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching).
Time frame: After 2 weeks of treatment
Overall improvement
Time frame: 2 weeks
Adverse events
Time frame: From initial day of treatment until treatment is stopped.
Laboratory tests
Time frame: At 7 or more days before treatment start, and after 2 weeks of treatment
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.
- Results publicationT. Ishikawa et. al; Practica otologica. Suppl.123 Page1-18 (2008.12) -Japanese language journal
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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 3 study testing mometasone furoate in people with Rhinitis, Allergic, Perennial, 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 7 inclusion and 14 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 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?
Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2. (time frame: After 2 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 NCT00779740, 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.