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COMPLETEDPHASE3

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

A Phase III, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Seasonal Allergic Rhinitis

NCT02320396•Organon and Co

View on ClinicalTrials.gov

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.

Eligibility

Age

16 - No limit years

Sex

ALL

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
+6 more criteria

Key Dates

Start Date

January 9, 2015

Primary Completion Date

April 27, 2015

Completion Date

April 27, 2015

Last Updated

May 17, 2024

Enrollment

449

ACTUAL participants

Conditions

Seasonal Allergic Rhinitis

Interventions

Desloratadine 5 mg

DRUG

Placebo

DRUG

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

A Clinical Pharmacology Study of MT-2990 in Seasonal Allergic Rhinitis Patients

Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen

To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray

Efficacy and Safety of Azelastine +Mometasone , Nasal Spray, 140 mcg + 50 mcg, (Sandoz d.d., Slovenia) and Momat Rino Advance, Nasal Spray, 140 mcg + 50 mcg, (Glenmark, India) Administered as a Monotherapy to Patients With Seasonal Allergic Rhinitis.

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis