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

September 14, 2017 updated by: ALK-Abelló A/S

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. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MK-8237 6 DU
MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days
Biological: MK-8237 6 DU
Other Names:
  • SCH 900237
EXPERIMENTAL: MK-8237 12 DU
MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days
Biological: MK-8237 12 DU
Other Names:
  • SCH 900237
PLACEBO_COMPARATOR: Placebo
Placebo rapidly dissolving tablet administered sublingually once daily for 28 days
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experienced At Least One Adverse Event (AE)
Time Frame: From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time Frame: From first dose to last dose of treatment, up to 28 days
The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.
From first dose to last dose of treatment, up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (ESTIMATE)

September 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8237-008
  • MK-8237-008 (OTHER: Merck Protocol Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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