Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)



Status:Completed
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - 17
Updated:3/30/2013
Start Date:October 2012
End Date:May 2013
Contact:Toll Free Number
Phone:1-888-577-8839

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Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (Protocol 008)


The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU]
and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust
mite-induced allergic rhinitis/rhinoconjunctivitis.

Study Hypothesis:

At least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents
with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.


Inclusion Criteria:

- History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of
at least 6 months duration (with or without asthma)

- 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:

- Unable to meet medication washout requirements

- 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 D. pteronyssinus and/or D. farinae) or self-injectable
epinephrine

- Business or personal relationship with investigational site personnel or Sponsor who
is directly involved with the conduct of the trial
We found this trial at
16
sites
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Naperville, IL
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Cleveland, OH
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High Point, North Carolina 27262
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High Point, NC
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Kansas City, MO
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from
Los Angeles, CA
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Mandeville, LA
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from
Miami, FL
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mi
from
Minneapolis, MN
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New Brunswick, New Jersey 08901
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from
New Brunswick, NJ
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mi
from
Plainsboro, NJ
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mi
from
Plymouth, MN
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mi
from
Portland, OR
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Redondo Beach, California 90277
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from
Redondo Beach, CA
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mi
from
San Antonio, TX
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San Antonio, TX
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mi
from
Upland, PA
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