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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01644617
First received: July 17, 2012
Last updated: September 23, 2013
Last verified: September 2013

July 17, 2012
September 23, 2013
October 2012
August 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01644617 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Rhinitis, Allergic, Perennial
  • Rhinitis, Allergic, Nonseasonal
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01644617
P07627, 2012-001855-38, 8237-003
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP