Trials / Completed
CompletedNCT01700192
Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,482 (actual)
- Sponsor
- ALK-Abelló A/S · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
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 rhinitis score (TCRS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MK-8237 tablets | MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. |
| BIOLOGICAL | Placebo tablets | Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. |
| 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. |
Timeline
- Start date
- 2013-01-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2012-10-04
- Last updated
- 2017-09-15
- Results posted
- 2017-03-03
Source: ClinicalTrials.gov record NCT01700192. Inclusion in this directory is not an endorsement.