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

NCT ID: NCT01918033

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 608 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-20
• Study Completion Date: 2014-01-26

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

Conditions

Perennial Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Desloratadine 5 mg

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

Group Type: EXPERIMENTAL

Desloratadine 5 mg

Intervention Type: DRUG

Desloratadine 5 mg tablets

Placebo

Intervention Type: DRUG

Matching placebo to desloratadine 5 mg tablets

Desloratadine 10 mg

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

Group Type: EXPERIMENTAL

Desloratadine 5 mg

Intervention Type: DRUG

Desloratadine 5 mg tablets

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to desloratadine 5 mg tablets

Interventions

Desloratadine 5 mg

Desloratadine 5 mg tablets

Intervention Type: DRUG

Placebo

Matching placebo to desloratadine 5 mg tablets

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Okamoto Y, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with perennial allergic rhinitis: A randomized controlled trial. J Clin Therapeut Med. 2016;32(12):967-978 [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=12

Reference Type: RESULT

Other Identifiers

132244

Identifier Type: REGISTRY

Identifier Source: secondary_id

4117-200

Identifier Type: -

Identifier Source: org_study_id