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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR MONTELUKAST SODIUM

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All Clinical Trials for Montelukast Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000577 Asthma Clinical Research Network (ACRN) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000622 Childhood Asthma Research and Education (CARE) Network Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1999-09-01 The purpose of this study is to evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.
NCT00092105 Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256) Completed Merck Sharp & Dohme Corp. Phase 3 2002-04-01 The purpose of this study is to determine the protective effect of an approved medication on asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure to cats.
NCT00092989 Investigation of Intravenous (IV) Administration of an Approved Drug (MK-0476, Montelukast Sodium) for Acute Asthma (MK-0476-288) Completed Merck Sharp & Dohme Corp. Phase 3 2004-07-01 The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug (MK-0476, montelukast sodium) in addition to approved standard treatment.
NCT00123630 A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab Completed Novartis Pharmaceuticals Phase 2 2005-11-01 Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults. The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising incidence of EE may be related to the worldwide allergy and asthma epidemic. Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have all been shown to be effective. However, none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects. The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE. Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related symptoms in patients with allergic asthma. The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis
NCT00123630 A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab Completed University of Utah Phase 2 2005-11-01 Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults. The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising incidence of EE may be related to the worldwide allergy and asthma epidemic. Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have all been shown to be effective. However, none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects. The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE. Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related symptoms in patients with allergic asthma. The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis
NCT00140881 A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165) Completed Merck Sharp & Dohme Corp. Phase 4 2000-06-01 A 53-week study to determine the effect of montelukast sodium when given to children (with infrequent episodic asthma) at the earliest symptoms of an acute episode of asthma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Montelukast Sodium

Condition Name

Condition Name for Montelukast Sodium
Intervention Trials
Asthma 20
Healthy 11
Lung Diseases 3
Allergic Rhinitis 3
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Condition MeSH

Condition MeSH for Montelukast Sodium
Intervention Trials
Asthma 15
Rhinitis 10
Rhinitis, Allergic 9
Lung Diseases 4
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Clinical Trial Locations for Montelukast Sodium

Trials by Country

Trials by Country for Montelukast Sodium
Location Trials
United States 30
India 12
Korea, Republic of 5
Poland 3
China 3
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Trials by US State

Trials by US State for Montelukast Sodium
Location Trials
North Dakota 4
Missouri 3
California 3
Wisconsin 3
New Jersey 2
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Clinical Trial Progress for Montelukast Sodium

Clinical Trial Phase

Clinical Trial Phase for Montelukast Sodium
Clinical Trial Phase Trials
Phase 4 11
Phase 3 11
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for Montelukast Sodium
Clinical Trial Phase Trials
Completed 44
Recruiting 3
Unknown status 2
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Clinical Trial Sponsors for Montelukast Sodium

Sponsor Name

Sponsor Name for Montelukast Sodium
Sponsor Trials
Merck Sharp & Dohme Corp. 13
Dr. Reddy's Laboratories Limited 6
Torrent Pharmaceuticals Limited 4
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Sponsor Type

Sponsor Type for Montelukast Sodium
Sponsor Trials
Industry 37
Other 16
NIH 4
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