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

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

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.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: Desloratadine 5 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 608
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desloratadine 5 mg; Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks	Drug: Desloratadine 5 mg; Desloratadine 5 mg tablets; Drug: Placebo; Matching placebo to desloratadine 5 mg tablets
Experimental: Desloratadine 10 mg; Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks	Drug: Desloratadine 5 mg; Desloratadine 5 mg tablets
Placebo Comparator: Placebo; Participants receive two placebo tablets orally once daily for up to 2 weeks	Drug: Placebo; Matching placebo to desloratadine 5 mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2	The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.	Baseline and Week 2
Number of Participants Experiencing an Adverse Event (AE)	An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.	Up to Week 4
Number of Participants Discontinuing Study Drug Due to an AE	An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.	Up to Week 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1	The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.	Baseline and Day 3, Week 1
Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator	The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.	Baseline and Day 3, Week 1, Week 2
Change From Baseline in Nasal Finding Score Assessed by the Investigator	The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.	Baseline and Day 3, Week 1, Week 2
Change From Baseline in Eye Symptom Score Assessed by the Investigator	The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.	Baseline and Day 3, Week 1, Week 2
Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator	The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.	Day 3, Week 1, Week 2
Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator	The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.	Baseline and Day 3, Week 1, Week 2
Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries	Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.	Baseline and Day 3, Week 1, Week 2
Change From Baseline in Eye Symptom Score Reported in Participant Diaries	Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.	Baseline and Day 3, Week 1, Week 2

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2013
• Primary Completion (Actual): January 26, 2014
• Study Completion (Actual): January 26, 2014

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Immune System Diseases; Allergic Rhinitis; Rhinitis; Histamine Antagonists; Neurotransmitter Agents; Histamine H1 Antagonists; Nose Diseases; Cholinergic Agents; Cholinergic Antagonists; Histamine H1 Antagonists, Non-Sedating; Histamine Agents
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Desloratadine
• Other Study ID Numbers: 4117-200; 132244 (Registry Identifier: JAPIC-CTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Study Data/Documents

1. CSR Synopsis