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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01700192
First received: October 2, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Nonseasonal
Biological: MK-8237 tablets
Biological: Placebo tablets
Drug: Rescue Medication: Self-Injectable Epinephrine
Drug: Rescue Medication: Loratadine tablets
Drug: Rescue Medication: Olopatadine ophthalmic drops
Drug: Rescue Medication: Mometasone furoate nasal spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Average Total Combined Rhinitis Score (TCRS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of Participants Who Experience At Least One Adverse Event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average Rhinitis Daily Symptom Score (Rhinitis DSS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Average Total Combined Rhinoconjunctivitis Score (TCS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Average Rhinitis Daily Medication Score (Rhinitis DMS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]
  • Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) [ Time Frame: Last 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: January 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-8237
MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily
Biological: MK-8237 tablets
MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily
Other Name: SCH 900237
Drug: Rescue Medication: Self-Injectable Epinephrine
Self-injectable epinephrine preferred dose of 0.30 mg administered intramuscularly as needed for rescue medication
Drug: Rescue Medication: Loratadine tablets
Loratadine tablet 10 mg administered orally as needed for rescue medication
Drug: Rescue Medication: Olopatadine ophthalmic drops
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication
Drug: Rescue Medication: Mometasone furoate nasal spray
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication
Placebo Comparator: Placebo
Placebo to MK-8237 rapidly dissolving tablets administered sublingually once daily
Biological: Placebo tablets

Placebo to MK-8237 rapidly dissolving tablets administered sublingually once

daily

Drug: Rescue Medication: Self-Injectable Epinephrine
Self-injectable epinephrine preferred dose of 0.30 mg administered intramuscularly as needed for rescue medication
Drug: Rescue Medication: Loratadine tablets
Loratadine tablet 10 mg administered orally as needed for rescue medication
Drug: Rescue Medication: Olopatadine ophthalmic drops
Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication
Drug: Rescue Medication: Mometasone furoate nasal spray
Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700192

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 133 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01700192     History of Changes
Other Study ID Numbers: P05607, MK-8237-001
Study First Received: October 2, 2012
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinephrine
Olopatadine
Loratadine
Mometasone furoate
Ophthalmic Solutions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics

ClinicalTrials.gov processed this record on September 18, 2014