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

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ClinicalTrials.gov Identifier: NCT00731185
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 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.

Condition or disease Intervention/treatment Phase
Nasal Polyps Drug: Mometasone Furoate Nasal Spray Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis
Actual Study Start Date : September 1, 2003
Actual Primary Completion Date : September 1, 2005
Actual Study Completion Date : September 1, 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning
Drug: Mometasone Furoate Nasal Spray
MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse
Other Names:
  • Nasonex
  • SCH 032088
Placebo Comparator: Placebo
Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning
Drug: Placebo
Other Name: Placebo (2 sprays of 50 mcg in each nostril) once daily in the morning for up to 24 weeks or until relapse



Primary Outcome Measures :
  1. Time to relapse in polyp score after surgery [ Time Frame: Assessment for relapse was performed at every study visit (up to 24 weeks of treatment) ]

Secondary Outcome Measures :
  1. Signs and symptom scores [ Time Frame: All study visits (up to 24 weeks of treatment) ]
  2. Quality of life, peak nasal inspiratory flow, olfaction threshold [ Time Frame: Measured starting 1 week after treatment up to 24 weeks of treatment ]
  3. Adverse events [ Time Frame: Throughout the whole study after the Screening period. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00731185     History of Changes
Other Study ID Numbers: P03218
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
functional
endoscopic
sinus
surgery

Additional relevant MeSH terms:
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents