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

Last updated: May 8, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Common Cold

Allergy

Nasal Obstruction

Treatment

Desloratadine 5 mg

Placebo

Clinical Study ID

NCT02320396
4117-204
MK-4117-204
152861
  • Ages > 16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, femalewho has reached natural menopause, or is of reproductive potential and agrees toeither remain abstinent or use (or have her partner use) 2 acceptable methods ofbirth control from study start through 14 days after the last dose of study drug.

Exclusion

Exclusion Criteria:

  • Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acutetonsillitis, etc.) requiring treatment

  • Has a coexisting infection or systemic mycosis for which there are no effectiveantibiotics

  • 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 receivedan investigational drug within prior 3 months

  • Has started specific desensitization therapy (allergen immunotherapy) or nonspecificallassotherapy (Histaglobin, vaccine therapy, etc.) or who has received suchtherapies within prior 3 months

  • Has received coagulation or resection using laser therapy etc. for treatment fornasal symptoms

  • Will receive nasal nebulizer therapy and/or thermotherapy during study period

  • Has severe hepatic, renal, cardiac, hematological disease, or other seriouscoexisting diseases and whose general condition is poor

  • Has a history of malignancy or clinically important hematological disorder, exceptfor adequately treated non-melanomatous skin carcinoma or carcinoma in situ of thecervix

  • 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 Periodor for more than 2 days during the Treatment Period.

Study Design

Total Participants: 449
Treatment Group(s): 2
Primary Treatment: Desloratadine 5 mg
Phase: 3
Study Start date:
January 09, 2015
Estimated Completion Date:
April 27, 2015

Study 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.

Connect with a study center

  • MSD K.K

    Chiyoda-Ku, Tokyo 102-8667
    Japan

    Site Not Available

  • MSD K.K.

    Chiyoda-Ku, Tokyo, 102-8667
    Japan

    Site Not Available

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