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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00453063 |
This study is designed to assess the effectiveness of MFNS once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total symptom score.
Condition | Intervention | Phase |
---|---|---|
Seasonal Allergic Rhinitis |
Drug: Mometasone furoate nasal spray |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 Mcg QD in the Treatment of Seasonal Allergic Rhinitis |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
Clinical laboratory test (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study.
Exclusion Criteria:
Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject's ability to complete or reliably complete the diaries.
Study ID Numbers: | P05067 |
Study First Received: | March 26, 2007 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00453063 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Mometasone furoate |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Rhinitis Anti-Allergic Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Otorhinolaryngologic Diseases Immune System Diseases Mometasone furoate Rhinitis Anti-Allergic Agents Pharmacologic Actions Nose Diseases |
Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis, Allergic, Seasonal Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |