Long-Term Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)



Status:Completed
Conditions:Allergy, Ocular
Therapuetic Areas:Ophthalmology, Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:11/8/2014
Start Date:January 2013
End Date:February 2015
Contact:Toll Free Number
Phone:1-888-577-8839

Use our guide to learn which trials are right for you!

A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)

The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in
the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis
(AR/ARC) in children and adults.

The primary hypothesis of this study is that administration of MK-8237, compared to placebo,
results in significant reduction in the average total combined rhinitis score (TCRS).


Inclusion Criteria:

- History of AR/ARC to house dust of 1 year duration or more (with or without asthma)

- If female of childbearing potential, has a negative urine pregnancy test at Screening
and agrees to remain abstinent or use (or have their partner use) an acceptable
method of birth control within the projected duration of the study

- Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:

- Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or
cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen

- History of symptomatic seasonal ARC and/or asthma due to an allergen to which the
participant is sensitized and regularly exposed

- Nasal condition that could confound the efficacy or safety assessments (e.g., nasal
polyposis)

- Received an immunosuppressive treatment within 3 months prior to screening

- Unstable 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 short-acting beta agonists [SABAs]) at any time within 3 months prior
to screening

- Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to
screening

- History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy,
unknown cause or inhalant allergen

- History of chronic urticaria and/or angioedema within 2 years prior to screening

- History of chronic sinusitis during 2 years prior to screening

- Pregnant, breastfeeding, or expecting to conceive within the projected duration of
the study

- Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5
years prior to screening

- Previous exposure to MK-8237

- Receiving ongoing treatment with any specific immunotherapy at screening

- Known history of allergy, hypersensitivity or intolerance to investigational
medicinal products (except for D. pteronyssinus and/or D. farinae), rescue
medications or self-injectable epinephrine

- Unable to meet medication washout requirements prior to screening

- Unable or unwilling to comply with the use of self-injectable epinephrine

- Business or personal relationship with investigational site personnel or Sponsor who
is directly involved with the conduct of the study

- Likely to travel for extended periods of time during the efficacy assessment period

- Participating in a different investigational study at any site during this study
We found this trial at
132
sites
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Allen, TX
Click here to add this to my saved trials
?
mi
from
Altoona, PA
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
Berkeley Heights, New Jersey 07922
?
mi
from
Berkeley Heights, NJ
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Blue Bell, PA
Click here to add this to my saved trials
?
mi
from
Boerne, TX
Click here to add this to my saved trials
?
mi
from
Brick, NJ
Click here to add this to my saved trials
?
mi
from
Brockton, MA
Click here to add this to my saved trials
?
mi
from
Brockton, MA
Click here to add this to my saved trials
?
mi
from
Broken Arrow, OK
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Columbia, MO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Corvallis, OR
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dublin, OH
Click here to add this to my saved trials
?
mi
from
Edison, NJ
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Ft. Mitchell, KY
Click here to add this to my saved trials
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
?
mi
from
Gaithersburg, MD
Click here to add this to my saved trials
?
mi
from
Gardner, MA
Click here to add this to my saved trials
?
mi
from
Goodyear, AZ
Click here to add this to my saved trials
?
mi
from
Greenfield, WI
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Harleysville, PA
Click here to add this to my saved trials
?
mi
from
Henrico, VA
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
Huntington Beach, California 92646
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, NE
Click here to add this to my saved trials
?
mi
from
Irvine, CA
Click here to add this to my saved trials
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Lake Oswego, OR
Click here to add this to my saved trials
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
?
mi
from
Lenexa, KS
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Little Silver, New Jersey 07739
?
mi
from
Little Silver, NJ
Click here to add this to my saved trials
?
mi
from
Live Oak, TX
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Medford, OR
Click here to add this to my saved trials
Mission Viejo, California 92691
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
?
mi
from
New Braunfels, TX
Click here to add this to my saved trials
?
mi
from
New Windsor, NY
Click here to add this to my saved trials
?
mi
from
Normal, IL
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
?
mi
from
Ocean, NJ
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
?
mi
from
Palmdale, CA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Providence, RI
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockville Centre, New York 11570
?
mi
from
Rockville Centre, NY
Click here to add this to my saved trials
?
mi
from
Rolla, MO
Click here to add this to my saved trials
?
mi
from
Roseville, CA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
San Jose, CA
Click here to add this to my saved trials