A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)

Organon

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: Placebo; Drug: Desloratadine 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01918033

132244 (Registry Identifier)

4117-200

Details and patient eligibility

About

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 placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.

Enrollment: 608 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with perennial allergic rhinitis
• Outpatient.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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608 participants in 3 patient groups, including a placebo group

Desloratadine 5 mg

Experimental group

Description:

Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks

Treatment:

Drug: Desloratadine 5 mg

Drug: Placebo

Desloratadine 10 mg

Experimental group

Description:

Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks

Treatment:

Drug: Desloratadine 5 mg

Placebo

Placebo Comparator group

Description:

Participants receive two placebo tablets orally once daily for up to 2 weeks

Treatment:

Drug: Placebo