CompletedPhase 3

Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)

162 participantsStarted 2003-09-01

Plain-language 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. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * At least 18 years of age * Bilateral nasal polyps * Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment) Exclusion Criteria: * 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to relapse in polyp score after surgery

Timeframe: Assessment for relapse was performed at every study visit (up to 24 weeks of treatment)

Trial details

NCT IDNCT00731185

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-09-01

View on ClinicalTrials.gov More Nasal Polyps trials