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

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Organon

Status and phase

Completed
Phase 3

Conditions

Nasal Polyps

Treatments

Drug: Mometasone Furoate Nasal Spray
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

162 participants in 2 patient groups, including a placebo group

Mometasone Furoate Nasal Spray (MFNS)
Experimental group
Description:
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning
Treatment:
Drug: Mometasone Furoate Nasal Spray
Placebo
Placebo Comparator group
Description:
Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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