Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

NCT ID: NCT02320396

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 449 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-09
• Study Completion Date: 2015-04-27

Brief Summary

This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.

Detailed Description

This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.

Conditions

Seasonal Allergic Rhinitis

Study Design

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

Study Groups

Desloratadine

After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period.

Group Type: EXPERIMENTAL

Desloratadine 5 mg

Intervention Type: DRUG

Desloratadine 5 mg tablets

Placebo

After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets

Interventions

Desloratadine 5 mg

Desloratadine 5 mg tablets

Intervention Type: DRUG

Placebo

Placebo tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms
• Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or use (or have her partner use) 2 acceptable methods of birth control from study start through 14 days after the last dose of study drug.

Exclusion Criteria

• Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment
• Has a coexisting infection or systemic mycosis for which there are no effective antibiotics
• Has asthma that is under treatment and/or uncontrolled
• Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed
• Has vasomotor rhinitis or eosinophilic rhinitis
• Has a history of hypersensitivity to antihistamines or ingredients of study drug
• Has had treatment with corticosteroids (oral, injectable, suppository, depot drugs [injectable]) or immunological drugs within 28 days prior to Visit 2
• Is currently receiving treatment with another investigational drug or has received an investigational drug within prior 3 months
• Has started specific desensitization therapy (allergen immunotherapy) or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who has received such therapies within prior 3 months
• Has received coagulation or resection using laser therapy etc. for treatment for nasal symptoms
• Will receive nasal nebulizer therapy and/or thermotherapy during study period
• Has severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
• Has a history of malignancy or clinically important hematological disorder, except for adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
• Has a history of severe drug allergy (e.g. anaphylactoid reaction)
• Is pregnant or lactating or may be pregnant
• Is planning a remote trip for more than 1 day during the Symptom Confirmation Period or for more than 2 days during the Treatment Period.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Okubo K, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with seasonal allergic rhinitis: A randomized controlled trial. Arerugi. 2016;32(11):863-876.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11

Reference Type: RESULT

Other Identifiers

152861

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-4117-204

Identifier Type: OTHER

Identifier Source: secondary_id

4117-204

Identifier Type: -

Identifier Source: org_study_id