Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)
This study is ongoing, but not recruiting participants.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01678807
First received: August 31, 2012
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU] and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.
Study Hypothesis:
At least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Perennial Rhinitis, Allergic, Nonseasonal |
Biological: MK-8237 6 DU Biological: MK-8237 12 DU Biological: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (Protocol 008) |
Further study details as provided by Merck:
Primary Outcome Measures:
- Percentage of Participants Who Experience At Least One Adverse Event [ Time Frame: Up to 42 days ] [ Designated as safety issue: Yes ]
- Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event [ Time Frame: Up to 28 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 195 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MK-8237 6 DU
MK-8237 6 DU rapidly dissolving tablet administered sublingually once daily for 28 days
|
Biological: MK-8237 6 DU
Other Name: SCH 900237
|
|
Experimental: MK-8237 12 DU
MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily for 28 days
|
Biological: MK-8237 12 DU
Other Name: SCH 900237
|
|
Placebo Comparator: Placebo
Placebo rapidly dissolving tablet administered sublingually once daily for 28 days
|
Biological: Placebo |
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma)
- History of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short acting beta-agonist [SABA] use per week; and not wakening more than twice a month at night due to asthma symptoms
- Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control from screening and through the duration of the study
Exclusion Criteria:
- Unable to meet medication washout requirements
- History of chronic urticaria and/or chronic angioedema within prior 2 years
- History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen
- Unstable, uncontrolled 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 SABAs) at any time within prior 3 months
- History of chronic sinusitis during within prior 2 years
- Pregnant or breast-feeding, or expecting to conceive within the projected duration of the study
- Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae) or self-injectable epinephrine
- Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the trial
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01678807 History of Changes |
| Other Study ID Numbers: | 8237-008, MK-8237-008 |
| Study First Received: | August 31, 2012 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013