Completed
Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (Protocol 008)
What is being tested
MK-8237 6 DU
+ MK-8237 12 DU
+ Placebo
Biological
Who is being recruted
Hypersensitivity+7
+ Hypersensitivity, Immediate
+ Immune System Diseases
From 12 to 17 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 1
Interventional
Study Start: October 2012
Summary
Principal SponsorALK-Abelló A/S
Last updated: September 15, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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. The primary hypothesis is that at least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.
Principal SponsorALK-Abelló A/S
Last updated: September 15, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
195 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 12 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
HypersensitivityHypersensitivity, ImmediateImmune System DiseasesNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRhinitisRhinitis, AllergicRhinitis, Allergic, Perennial
Criteria
3 inclusion criteria required to participate
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
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
History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma)
8 exclusion criteria prevent from participating
Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the trial
History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen
History of chronic sinusitis during within prior 2 years
History of chronic urticaria and/or chronic angioedema within prior 2 years
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalMK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days
Group II
ExperimentalMK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days
Group III
PlaceboPlacebo rapidly dissolving tablet administered sublingually once daily for 28 days
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers