Montelukast

Generic Name
Montelukast
Brand Names
Singulair
Drug Type
Small Molecule
Chemical Formula
C35H36ClNO3S
CAS Number
158966-92-8
Unique Ingredient Identifier
MHM278SD3E
Background

Montelukast was first approved for clinical use by the US FDA in 1998 as Merck's brand name Singulair. The medication is a member of the leukotriene receptor antagonist (LTRA) category of drugs. Although capable of demonstrating effectiveness, the use of such LTRAs like montelukast is typically in addition to or complementary with the use of inhaled corticos...

Indication

Montelukast is indicated for:
...

Associated Conditions
Asthma, Exercise-Induced Bronchospasm, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis
Associated Therapies
-

Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-08-08
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
35
Registration Number
NCT01659918
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-08-08
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
35
Registration Number
NCT01659905
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients

First Posted Date
2012-07-13
Last Posted Date
2013-04-08
Lead Sponsor
Hanmi Pharmaceutical Company Limited
Target Recruit Count
283
Registration Number
NCT01640535
Locations
🇰🇷

Soonchunhyang University Bucheon Hospital, Bucheon, Gyeonggi-do, Korea, Republic of

Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-06-18
Last Posted Date
2017-04-20
Lead Sponsor
Hal C Charles
Target Recruit Count
34
Registration Number
NCT01621386
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Effects of Montelukast in Asthmatic Children With and Without Food Allergy

Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-06-13
Last Posted Date
2017-08-14
Lead Sponsor
Hacettepe University
Target Recruit Count
113
Registration Number
NCT01618929
Locations
🇹🇷

Cansin Sackesen, Ankara, Turkey

Individualized Therapy For Asthma in Toddlers

First Posted Date
2012-05-25
Last Posted Date
2017-03-16
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
300
Registration Number
NCT01606306
Locations
🇺🇸

St. Louis Children's Hospital, St. Louis, Missouri, United States

🇺🇸

University of Wisconsin-Madison, Madison, Wisconsin, United States

🇺🇸

University of Arizona College of Medicine, Tucson, Arizona, United States

and more 10 locations

A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-03-12
Last Posted Date
2013-04-30
Lead Sponsor
Ono Pharma USA Inc
Target Recruit Count
25
Registration Number
NCT01551147
Locations
🇨🇦

Calgary Clinical Site 540, Alberta, Canada

🇨🇦

Hamilton Clinical Site 550, Ontario, Canada

🇨🇦

Saskatoon Clinical Site 520, Saskatoon, Canada

and more 2 locations

A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-02-20
Last Posted Date
2014-02-14
Lead Sponsor
Ono Pharma USA Inc
Target Recruit Count
59
Registration Number
NCT01536041
Locations
🇺🇸

Raleigh Clinical Site 130, Raleigh, North Carolina, United States

🇺🇸

Denver Clinical Site 160, Denver, Colorado, United States

🇺🇸

San Diego Clinical Site 140, San Diego, California, United States

and more 6 locations

Management of Asthma in School-age Children on Therapy

First Posted Date
2012-02-03
Last Posted Date
2012-02-03
Lead Sponsor
Professor Warren Lenney
Target Recruit Count
229
Registration Number
NCT01526161

A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

First Posted Date
2011-10-24
Last Posted Date
2020-10-30
Lead Sponsor
Children's Mercy Hospital Kansas City
Target Recruit Count
4
Registration Number
NCT01458418
Locations
🇺🇸

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

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