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

Organon

Status and phase: Completed; Phase 3

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Desloratadine 5 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02320396

152861 (Registry Identifier)

4117-204

MK-4117-204 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 449 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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449 participants in 2 patient groups, including a placebo group

Desloratadine

Experimental group

Description:

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.

Treatment:

Drug: Desloratadine 5 mg

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo