Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)
NCT ID: NCT01678807
Last Updated: 2017-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
195 participants
INTERVENTIONAL
2012-10-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MK-8237 6 DU
MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days
MK-8237 6 DU
MK-8237 12 DU
MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days
MK-8237 12 DU
Placebo
Placebo rapidly dissolving tablet administered sublingually once daily for 28 days
Placebo
Interventions
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MK-8237 6 DU
MK-8237 12 DU
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short acting beta-agonist \[SABA\] use per week; and not wakening more than twice a month at night due to asthma symptoms
* Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control from screening and through the duration of the study
Exclusion Criteria
* History of chronic urticaria and/or chronic angioedema within prior 2 years
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen
* Unstable, uncontrolled or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing SABAs) at any time within prior 3 months
* History of chronic sinusitis during within prior 2 years
* Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
* Known history of allergy, hypersensitivity or intolerance to investigational medicinal products except for Dermatophagoides pteronyssinus (D. pteronyssinus) and/or Dermatophagoides farina (D. farina) or self-injectable epinephrine
* Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the trial
12 Years
17 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
ALK-Abelló A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Maloney J, Prenner BM, Bernstein DI, Lu S, Gawchik S, Berman G, Kaur A, Li Z, Nolte H. Safety of house dust mite sublingual immunotherapy standardized quality tablet in children allergic to house dust mites. Ann Allergy Asthma Immunol. 2016 Jan;116(1):59-65. doi: 10.1016/j.anai.2015.10.024. Epub 2015 Nov 6.
Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.
Other Identifiers
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MK-8237-008
Identifier Type: OTHER
Identifier Source: secondary_id
8237-008
Identifier Type: -
Identifier Source: org_study_id