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

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00731185

First received: August 5, 2008

Last updated: August 7, 2008

Last verified: August 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	August 5, 2008
Last Updated Date	August 7, 2008
Start Date ^ICMJE	September 2003
Primary Completion Date	September 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 7, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00731185 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 7, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)(COMPLETED)
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Nasal Polyps
Intervention ^ICMJE	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 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
Study Arm (s)	Experimental: Mometasone Furoate Nasal Spray (MFNS) MFNS 200 mcg (2 sprays of 50 mcg in each nostril) once daily in the morning Intervention: Drug: Mometasone Furoate Nasal Spray Placebo Comparator: Placebo Placebo nasal spray (2 sprays of 50 mcg in each nostril) once daily in the morning Intervention: Drug: Placebo
Publications *	Stjärne P, Olsson P, Alenius M. Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):296-302.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	162
Completion Date	September 2005
Primary Completion Date	September 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00731185
Other Study ID Numbers ^ICMJE	P03218
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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