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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00731185
First received: August 5, 2008
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Nasal Polyps
Drug: Mometasone Furoate Nasal Spray
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Signs and symptom scores [ Time Frame: All study visits (up to 24 weeks of treatment) ] [ Designated as safety issue: No ]
  • Quality of life, peak nasal inspiratory flow, olfaction threshold [ Time Frame: Measured starting 1 week after treatment up to 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout the whole study after the Screening period. ] [ Designated as safety issue: Yes ]

Enrollment: 162
Study Start Date: September 2003
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional 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
Study First Received: August 5, 2008
Last Updated: April 25, 2014
Health Authority: Sweden: Medical Products Agency

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
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 26, 2014