Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays (PHT-01-12)
Recruitment status was Not yet recruiting
Demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED, CLINICAL STUDY TO DEMONSTRATE THE THERAPEUTIC CLINICAL EQUIVALENCE OF TWO MOMETASONE NASAL SPRAYS IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS.|
- demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of perennial allergic rhinitis, in term of changes at week 8 from baseline of Total Nasal Symptom Scores (TNSS). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
- Safety monitoring AE, routine laboratory haematology, biochemical tests, urinalysis, assessment of adrenal function to be sure of lack of systemic effect of nasal spray formulation Overall Patient's and Physician's global assessment. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Patients at week 8 with a 50% reduction in TNSS mean change from baseline. Symptom-free days. The mean change from baseline to week 8 for mean Total Non Nasal Symptom Scores (TNNSS).
Use of rescue medication (Time Frame: 8 weeks). Individual patient-rated symptoms evaluation. Clinical Global Improvement (CGI) evaluation.
That includes description of the patient's adherence to the optimal prolonged treatment.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Mometasone, nasal spray for 8 weeks, 2 actuations each nostril in the morning.
|Drug: Mometasone furoate|
Active Comparator: Nasonex®
Nasonex nasal spray for 8 weeks 2 actuations each nostril in the morning.
|Drug: Mometasone furoate|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702103
|Contact: Josè Eg Fabiani, Doctor||(00 54 11) 4983-1228|
|Swiss Medical Group||Not yet recruiting|
|Buenos Aires, Capital Federal, Argentina, C1118AAE|
|Contact: Carlos DEBASA, Dr. 0810-333-8876|
|Principal Investigator: Carlos Debasa, Doctor|
|Study Director:||Alessandro Mazzetti, MD||Sintesi Research Srl|