A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (P07627 AM1)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01644617

First received: July 17, 2012

Last updated: May 9, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 17, 2012
Last Updated Date	May 9, 2013
Start Date ^ICMJE	October 2012
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 17, 2012)	Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Sessions [ Time Frame: 6 months ] [ Designated as safety issue: No ] TNSS is the total of scores for 4 nasal symptoms (itchy nose, blocked nose, runny nose, and sneezing), each scored on a 4-point rating scale (0=no symptoms to 3=severe symptoms; TNSS range: 0 to 12 points).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01644617 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 17, 2012)	Average Total Symptom Score (TSS) During EEC Challenge Sessions [ Time Frame: 6 months ] [ Designated as safety issue: No ] TSS is the sum of the TNSS and Total Ocular Symptom Score (TOSS). TOSS is the total of scores for 2 ocular symptom scores (gritty/feeling/red/itchy eyes and watery eyes), each scored on a 4-point scale (0=no symptoms to 3=severe symptoms; TOSS range: 0 to 6 points). (TSS range: 0 to 18 points). Average Total Ocular Symptom Score (TOSS) During EEC Challenge Sessions [ Time Frame: 6 months ] [ Designated as safety issue: No ] HDM-specific Immunoglobulin E (IgE) and HDM-specific Immunoglobulin G4 (IgG4) Levels [ Time Frame: Week 8 ] [ Designated as safety issue: No ] Change from Pre-treatment in HDM-specific IgE and HDM-specific IgG4 Levels [ Time Frame: Pre-treatment (Week -6) and Week 8 ] [ Designated as safety issue: No ] Number of Participants Who Experience At Least One Adverse Event (AE) [ Time Frame: From first dose of study drug through to 2 weeks after last dose of study drug (up to 26 weeks) ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (P07627 AM1)
Official Title ^ICMJE	A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 Using an Environmental Exposure Chamber in Subjects With House Dust Induced Allergic Rhinitis/Rhinoconjunctivitis
Brief Summary	The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of HDM-induced allergic rhinitis/rhinoconjunctivitis in adults. Hypothesis: Administration of MK-8237, compared to placebo, results in dose-related improvement in Average Total Nasal Symptom Score (TNSS) during Environmental Exposure Chamber (EEC) Challenge.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Rhinitis, Allergic, Perennial Rhinitis, Allergic, Nonseasonal
Intervention ^ICMJE	Drug: Placebo Placebo rapidly dissolving tablets administered sublingually once daily Drug: MK-8237 6 Development Units (DU) MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily Other Name: SCH 900237 Drug: MK-8237 12 DU MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily Other Name: SCH 900237
Study Arm (s)	Placebo Comparator: Placebo Intervention: Drug: Placebo Experimental: MK-8237 6 DU Intervention: Drug: MK-8237 6 Development Units (DU) Experimental: MK-8237 12 DU Intervention: Drug: MK-8237 12 DU
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	120
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: history of allergic rhinitis/rhinoconjunctivitis 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) 2 acceptable methods of birth control within the projected duration of the study. Exclusion Criteria: sensitized and regularly exposed to animal dander and molds, (e.g. present in the home, job, etc.) sensitized and regularly exposed to seasonal allergens (i.e., Birch or grass pollen) immunosuppressive treatment within 3 months prior to Screening (except steroids for allergic and asthma symptoms) history of chronic urticaria and/or angioedema within 2 years prior to Screening previous immunotherapy treatment with any HDM allergen for more than 1 month within 3 years prior to Screening ongoing treatment with any specific immunotherapy history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, due to an unknown cause or to an inhalant allergen unstable uncontrolled/partially controlled or severe asthma, or 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 [SABA]) within 3 months prior to Screening asthma requiring medium- or high-dose inhaled corticosteroid (ICS) within 12 months prior to Screening chronic sinusitis within 2 years prior to Screening nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps) pregnant, breastfeeding or planning to become pregnant during the study participation in a different investigational study at any site during the same time frame of this study direct association with the administration of the study or a family member of the study staff
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01644617
Other Study ID Numbers ^ICMJE	P07627, 2012-001855-38, 8237-003
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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