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Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR BROMPHENIRAMINE MALEATE


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505(b)(2) Clinical Trials for Brompheniramine Maleate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00894634 ↗ Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2009-03-21 The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Brompheniramine Maleate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00894634 ↗ Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2009-03-21 The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12 yrs and adolescents aged 12 to <18 yrs.
NCT01177852 ↗ Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis Withdrawn Ache Laboratorios Farmaceuticos S.A. Phase 3 2011-10-01 Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
NCT01393548 ↗ Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis Completed Ache Laboratorios Farmaceuticos S.A. Phase 3 2014-08-01 This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
NCT01393561 ↗ Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis Completed Ache Laboratorios Farmaceuticos S.A. Phase 3 2014-07-01 This is a multicenter clinical trial, phase III, superiority, controlled by active medicine, double-blind, randomized, enroll 166 children, over 12 years old, with acute inflammation upper airway, characterized by nasal congestion and runny nose, lasting at least 24 hours and a maximum of 48 hours prior to inclusion. The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Brompheniramine Maleate

Condition Name

Condition Name for Brompheniramine Maleate
Intervention Trials
Rhinitis 3
Nasal Congestion and Inflammations 2
Allergic Reactions 1
Cough 1
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Condition MeSH

Condition MeSH for Brompheniramine Maleate
Intervention Trials
Rhinitis 3
Inflammation 3
Cough 1
Common Cold 1
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Clinical Trial Locations for Brompheniramine Maleate

Trials by Country

Trials by Country for Brompheniramine Maleate
Location Trials
Brazil 1
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Clinical Trial Progress for Brompheniramine Maleate

Clinical Trial Phase

Clinical Trial Phase for Brompheniramine Maleate
Clinical Trial Phase Trials
Phase 3 3
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Brompheniramine Maleate
Clinical Trial Phase Trials
Completed 3
Withdrawn 1
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Clinical Trial Sponsors for Brompheniramine Maleate

Sponsor Name

Sponsor Name for Brompheniramine Maleate
Sponsor Trials
Ache Laboratorios Farmaceuticos S.A. 3
Wyeth is now a wholly owned subsidiary of Pfizer 1
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Sponsor Type

Sponsor Type for Brompheniramine Maleate
Sponsor Trials
Industry 4
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