Overview

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

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Mometasone Furoate
Criteria
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