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项与 阿托品/氯苯那敏/伪麻黄碱 相关的临床试验A Phase 2, Double-Blind, Parallel-Group, Dose-Ranging Study Evaluating Safety/ Efficacy Atropine Doses With Pseudoephedrine and Chlorpheniramine in SAR Patients 12 Years of Age and Older
This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by statistical significance where p < 0.05.
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult and Adolescent Subjects With a History of Seasonal Allergic Rhinitis
The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to assess and compare the safety and efficacy of the study drug in a larger group comparatively with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B) Report any side effects or adverse drug reactions and rate the severity of any incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip symptom scores (PND-S) between the two study arms.
A Bi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult Subjects With a History of Seasonal Allergic Rhinitis
To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on placebo.
100 项与 阿托品/氯苯那敏/伪麻黄碱 相关的临床结果
100 项与 阿托品/氯苯那敏/伪麻黄碱 相关的转化医学
100 项与 阿托品/氯苯那敏/伪麻黄碱 相关的专利(医药)
100 项与 阿托品/氯苯那敏/伪麻黄碱 相关的药物交易