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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE


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All Clinical Trials for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01293201 ↗ Trial of STAHIST in Seasonal Allergic Rhinitis Completed Magna Pharmaceuticals, Inc. Phase 3 2011-03-01 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.
NCT02246166 ↗ The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza. Completed Sino-American Tianjin Smith Kline & French Laboratories Ltd Phase 4 2015-01-01 This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.
NCT02246166 ↗ The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza. Completed GlaxoSmithKline Phase 4 2015-01-01 This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride

Condition Name

Condition Name for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Intervention Trials
Common Cold 1
Seasonal Allergic Rhinitis 1
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Condition MeSH

Condition MeSH for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Intervention Trials
Rhinitis, Allergic, Seasonal 1
Rhinitis, Allergic 1
Rhinitis 1
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Clinical Trial Locations for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride

Trials by Country

Trials by Country for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Location Trials
United States 6
China 1
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Trials by US State

Trials by US State for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Location Trials
Texas 1
South Carolina 1
Ohio 1
Kentucky 1
Indiana 1
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Clinical Trial Progress for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Clinical Trial Phase Trials
Completed 2
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Clinical Trial Sponsors for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride

Sponsor Name

Sponsor Name for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Sponsor Trials
Magna Pharmaceuticals, Inc. 1
Sino-American Tianjin Smith Kline & French Laboratories Ltd 1
GlaxoSmithKline 1
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Sponsor Type

Sponsor Type for Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride
Sponsor Trials
Industry 2
Other 1
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