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
Springfield, Massachusetts 01199
2501
mi
from 91732
Springfield, MA
Click here to add this to my saved trials
1227
mi
from 91732
Allen, TX
Click here to add this to my saved trials
2203
mi
from 91732
Altoona, PA
Click here to add this to my saved trials
1932
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
1932
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
1204
mi
from 91732
Arlington, TX
Click here to add this to my saved trials
2002
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
2686
mi
from 91732
Bangor, ME
Click here to add this to my saved trials
1300
mi
from 91732
Bellevue, NE
Click here to add this to my saved trials
1039
mi
from 91732
Bellingham, WA
Click here to add this to my saved trials
Berkeley Heights, New Jersey 07922
2410
mi
from 91732
Berkeley Heights, NJ
Click here to add this to my saved trials
2361
mi
from 91732
Bethlehem, PA
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2368
mi
from 91732
Blue Bell, PA
Click here to add this to my saved trials
1166
mi
from 91732
Boerne, TX
Click here to add this to my saved trials
2430
mi
from 91732
Brick, NJ
Click here to add this to my saved trials
2581
mi
from 91732
Brockton, MA
Click here to add this to my saved trials
2581
mi
from 91732
Brockton, MA
Click here to add this to my saved trials
1261
mi
from 91732
Broken Arrow, OK
Click here to add this to my saved trials
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
2467
mi
from 91732
Burlington, VT
Click here to add this to my saved trials
2044
mi
from 91732
Canton, OH
Click here to add this to my saved trials
Charleston, South Carolina 29412
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
1554
mi
from 91732
Chesterfield, MO
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
1462
mi
from 91732
Columbia, MO
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
776
mi
from 91732
Corvallis, OR
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1953
mi
from 91732
Dublin, OH
Click here to add this to my saved trials
2413
mi
from 91732
Edison, NJ
Click here to add this to my saved trials
686
mi
from 91732
El Paso, TX
Click here to add this to my saved trials
2422
mi
from 91732
Elizabeth, NJ
Click here to add this to my saved trials
82
mi
from 91732
Encinitas, CA
Click here to add this to my saved trials
744
mi
from 91732
Eugene, OR
Click here to add this to my saved trials
2315
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
207
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
1877
mi
from 91732
Ft. Mitchell, KY
Click here to add this to my saved trials
1943
mi
from 91732
Gainesville, GA
Click here to add this to my saved trials
2271
mi
from 91732
Gaithersburg, MD
Click here to add this to my saved trials
2529
mi
from 91732
Gardner, MA
Click here to add this to my saved trials
332
mi
from 91732
Goodyear, AZ
Click here to add this to my saved trials
1723
mi
from 91732
Greenfield, WI
Click here to add this to my saved trials
Greenville, South Carolina 29605
2019
mi
from 91732
Greenville, SC
Click here to add this to my saved trials
2361
mi
from 91732
Harleysville, PA
Click here to add this to my saved trials
2269
mi
from 91732
Henrico, VA
Click here to add this to my saved trials
2141
mi
from 91732
High Point, NC
Click here to add this to my saved trials
Huntington Beach, California 92646
28
mi
from 91732
Huntington Beach, CA
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from 91732
Iowa City, NE
Click here to add this to my saved trials
33
mi
from 91732
Irvine, CA
Click here to add this to my saved trials
1546
mi
from 91732
Jonesboro, AR
Click here to add this to my saved trials
1925
mi
from 91732
Knoxville, TN
Click here to add this to my saved trials
1578
mi
from 91732
La Crosse, WI
Click here to add this to my saved trials
99
mi
from 91732
La Jolla, CA
Click here to add this to my saved trials
822
mi
from 91732
Lake Oswego, OR
Click here to add this to my saved trials
1939
mi
from 91732
Lawrenceville, GA
Click here to add this to my saved trials
1332
mi
from 91732
Lenexa, KS
Click here to add this to my saved trials
1463
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
Little Silver, New Jersey 07739
2433
mi
from 91732
Little Silver, NJ
Click here to add this to my saved trials
1238
mi
from 91732
Live Oak, TX
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
1654
mi
from 91732
Madison, WI
Click here to add this to my saved trials
627
mi
from 91732
Medford, OR
Click here to add this to my saved trials
1511
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
Mission Viejo, California 92691
37
mi
from 91732
Mission Viejo, CA
Click here to add this to my saved trials
1203
mi
from 91732
New Braunfels, TX
Click here to add this to my saved trials
2429
mi
from 91732
New Windsor, NY
Click here to add this to my saved trials
1648
mi
from 91732
Normal, IL
Click here to add this to my saved trials
North Hollywood, California 91606
21
mi
from 91732
North Hollywood, CA
Click here to add this to my saved trials
2433
mi
from 91732
Ocean, NJ
Click here to add this to my saved trials
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
1741
mi
from 91732
Owensboro, KY
Click here to add this to my saved trials
37
mi
from 91732
Palmdale, CA
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
1227
mi
from 91732
Plano, TX
Click here to add this to my saved trials
1501
mi
from 91732
Plymouth, MN
Click here to add this to my saved trials
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
2562
mi
from 91732
Providence, RI
Click here to add this to my saved trials
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
333
mi
from 91732
Redwood City, CA
Click here to add this to my saved trials
2267
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
Rockville Centre, New York 11570
2452
mi
from 91732
Rockville Centre, NY
Click here to add this to my saved trials
1485
mi
from 91732
Rolla, MO
Click here to add this to my saved trials
368
mi
from 91732
Roseville, CA
Click here to add this to my saved trials
364
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
1573
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
355
mi
from 91732
San Francisco, CA
Click here to add this to my saved trials