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.
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