Status:
COMPLETED
A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
Lead Sponsor:
Organon and Co
Conditions:
Perennial Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to pl...
Eligibility Criteria
Inclusion
- Diagnosed with perennial allergic rhinitis
- Outpatient.
Exclusion
- Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.)
- Coexisting infections or systemic mycosis for which there are no effective antibiotics
- Asthma complication under treatment
- Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed
- Vasomotor rhinitis or eosinophilic rhinitis
- Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug
- History of hypersensitivity to antihistamines or study drug
- Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months
- Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent
- Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
- History of malignancy or clinically important hematological disorder
- History of severe drug allergy (e.g., anaphylactoid reaction).
Key Trial Info
Start Date :
August 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2014
Estimated Enrollment :
608 Patients enrolled
Trial Details
Trial ID
NCT01918033
Start Date
August 20 2013
End Date
January 26 2014
Last Update
June 18 2024
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