Nasal PolypsPhase 3NCT00731185
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
A Phase 3 study testing Mometasone Furoate Nasal Spray in people with Nasal Polyps, run by Organon and Co.
Trial summary
This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Mometasone Furoate Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2003to 1 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Bilateral nasal polyps
- Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)
Who cannot join
- Polypectomy within the last 6 months
- Unhealed nasal surgery/trauma
- >5 previous polypectomies
- Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods
- Nasal infection
- Pulmonary tuberculosis
Show all 14Show fewer
- Cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease
- Immunocompromised
- Rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants)
- Known hereditary mucociliary dysfunction
- Significant nasal structure abnormalities
- Asthmatic attack within the past 30 days
- Asthmatic patients requiring >1000 mcg beclomethasone or equivalent
- Asthmatic patients not stable on corticosteroid therapy
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis
This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.
- Conditions
- Nasal Polyps
- Being tested
- Mometasone Furoate Nasal Spray, Placebo
- Keywords
- functional, endoscopic, sinus, surgery
- Medical subject headings
- Nasal Polyps, Fistula
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 Nasonex, SCH 032088
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
PlaceboDrug
Also called Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning Receives: Drug: Mometasone Furoate Nasal Spray |
| Placebo | Placebo comparator | Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse in polyp score after surgery
Measured: Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)
Secondary outcomes (3)
Signs and symptom scores
Measured: All study visits (up to 24 weeks of treatment)
Quality of life, peak nasal inspiratory flow, olfaction threshold
Measured: Measured starting 1 week after treatment up to 24 weeks of treatment
Adverse events
Measured: Throughout the whole study after the Screening period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study start1 Sep 2003
- Primary completion1 Sep 2005
- Study completion1 Sep 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 Nasal PolypsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 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
- NCT00731185
- Sponsor's protocol ID
- P03218
- Status last verified
- Feb 2022
- First submitted
- 5 Aug 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):296-302. doi: 10.1001/archoto.2009.2.
PubMed 19289710
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 Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis
- ClinicalTrials.gov ID
- NCT00731185
- Acronym / sponsor ID
- P03218
- Conditions
- Nasal Polyps
- Keywords
- functional, endoscopic, sinus, surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2003 (actual)
- Primary completion
- 1 Sep 2005 (actual)
- Study completion
- 1 Sep 2005 (actual)
- First posted
- 8 Aug 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 study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | Drug: Mometasone Furoate Nasal SprayMFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Bilateral nasal polyps
- Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)
Key exclusion criteria (14 listed)
- Polypectomy within the last 6 months
- Unhealed nasal surgery/trauma
- >5 previous polypectomies
- Female of childbearing age who is pregnant, lactating, or not using active contraceptive methods
- Nasal infection
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: Nasonex, SCH 032088MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse | Drug | Mometasone Furoate Nasal Spray (MFNS) |
| PlaceboAlso: Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse | Drug | Placebo |
Primary outcome
Time to relapse in polyp score after surgery
Time frame: Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)
3 secondary outcomes
Signs and symptom scores
Time frame: All study visits (up to 24 weeks of treatment)
Quality of life, peak nasal inspiratory flow, olfaction threshold
Time frame: Measured starting 1 week after treatment up to 24 weeks of treatment
Adverse events
Time frame: Throughout the whole study after the Screening period.
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.
- Derived from this study: PubMed 19289710Stjarne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):296-302. doi: 10.1001/archoto.2009.2.
Related trials for Nasal Polyps
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
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 Nasal Spray in people with Nasal Polyps, 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 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. 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?
Time to relapse in polyp score after surgery (time frame: Assessment for relapse was performed at every study visit (up to 24 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 NCT00731185, 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.