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

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 daily symptom and medication scores (TCS).

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. P05607/001-00)

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine Loratadine Mometasone furoate Olopatadine Olopatadine hydrochloride Mometasone furoate monohydrate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Average Total Combined Daily Symptom and Medication Scores (TCS) [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
Number of Participants Who Experience At Least One Adverse Event [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Number of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Average Daily Symptom Score (DSS) [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
Average Visual Analogue Scale (VAS) Score [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
Average Daily Medication Score (DMS) [ Time Frame: Week 44 to Week 52 ] [ Designated as safety issue: No ]
Average Total Nasal Symptom Score (TNSS) [ Time Frame: Week 44 to Week 52 ] [ 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

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:

Sensitized and regularly exposed to 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 (except steroids for allergic and asthma symptoms)
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
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

Contacts and Locations

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

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 96 Study Locations

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01700192 History of Changes
Other Study ID Numbers:	P05607, MK-8237-001
Study First Received:	October 2, 2012
Last Updated:	May 16, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rhinitis
Rhinitis, Allergic, Perennial
Conjunctivitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Epinephrine
Epinephryl borate

Loratadine
Olopatadine
Mometasone furoate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013