Status:
COMPLETED
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
Lead Sponsor:
Organon and Co
Conditions:
Nasal Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Sc...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Bilateral nasal polyps
- Fulfill criteria for polypectomy (be indicated for surgical - FESS - treatment)
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00731185
Start Date
September 1 2003
End Date
September 1 2005
Last Update
August 15 2024
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