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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01644617
First received: July 17, 2012
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Perennial Rhinitis, Allergic, Nonseasonal |
Drug: Placebo Drug: MK-8237 6 Development Units (DU) Drug: MK-8237 12 DU |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Further study details as provided by Merck:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo rapidly dissolving tablets administered sublingually once daily
|
| Experimental: MK-8237 6 DU |
Drug: MK-8237 6 Development Units (DU)
MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily
Other Name: SCH 900237
|
| Experimental: MK-8237 12 DU |
Drug: MK-8237 12 DU
MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily
Other Name: SCH 900237
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01644617 History of Changes |
| Other Study ID Numbers: | P07627, 2012-001855-38, 8237-003 |
| Study First Received: | July 17, 2012 |
| Last Updated: | May 9, 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 |
ClinicalTrials.gov processed this record on May 19, 2013