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 range18 Years

SexALL

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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

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