Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays (PHT-01-12)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01702103|
Recruitment Status : Unknown
Verified October 2012 by PH&T S.p.A..
Recruitment status was: Not yet recruiting
First Posted : October 5, 2012
Last Update Posted : October 5, 2012
|Condition or disease||Intervention/treatment||Phase|
|Nasal Obstruction Sneezing Itching||Drug: Mometasone furoate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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.|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||March 2013|
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
- 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 ]
- 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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01702103
|Contact: Josè Eg Fabiani, Doctor||(00 54 11) 4983-1228|
|Swiss Medical Group|
|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|