NCT00932256|CompletedPhase 1DMC
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
STAHIST IND 105781 Phase 1 Clinical Trial
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Sponsor study identifier
interventional
21
1 country
1
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2009
Actual (reported)Study Completion
December 2010
Actual (reported)MAGNA intends to show that the combination of pseudoephedrine, chlorpheniramine, plus a small amount of belladonna alkaloid is a comprehensive, safe and effective twice daily (BID) drug treatment for seasonal allergic rhinitis (SAR) patients with post-nasal drip (PND). The phase 1 single-dose trial will consist of 21 subjects: 1) to gather pharmacodynamic measurements and blood levels of active ingredients over 12 hours; 2) To report subjective scores by subjects rating efficacy of single dose of STAHIST; 3) To report any side effects or adverse drug reactions and rate the severity of incidence.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 30, 2009
Actual (reported)July 3, 2009
Actual (reported)October 2009
Date type not reportedThis date has not been verified as actual or estimated.
October 2009
Actual (reported)December 2010
Actual (reported)To gather pharmacodynamic measurements and assess blood levels (five draws) of the active ingredients in STAHIST over the dosage interval period of 12 hours.
August 2009
To report any side effects or adverse drug reactions and rate the severity of incidence.
August 2009
STAHIST for seasonal allergic rhinitis: each white, scored tablet contains pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, and atropine sulfate .24mg
Oral tablet containing Pseudoephedrine hydrochloride 90mg, chlorpheniramine maleate 8mg, atropine sulfate .24mg, one tablet BID.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Family Allergy and Asthma Research Institute
Louisville, Kentucky, 40215, United States
Moffitt EM. Symptomatic management of upper respiratory allergies. J Miss State Med Assoc. 1968 Apr;9(4):159-61. No abstract available.
Stephen J Pollard, MD
Family Allergy and Asthma Research Institute
21 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2009
First Posted
July 3, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Trial of STAHIST in Seasonal Allergic Rhinitis
Contact the study team to confirm eligibility.
Primary Completion
October 2009
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
December 8, 2010
Record last verified: 2010-12
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Source: ClinicalTrials.gov.
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