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

NCT01918033 | Completed Phase 3 Results

• 2 other identifiers: 4117-200132244
• Study Type: interventional
• Target: 608
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Perennial Allergic Rhinitis

Keywords

Rhinitis; Allergic Rhinitis; Nose Diseases; Respiratory Tract Diseases; Immune System Diseases; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1

  Baseline and Day 3, Week 1

• Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator

  Baseline and Day 3, Week 1, Week 2

• Change From Baseline in Nasal Finding Score Assessed by the Investigator

  Baseline and Day 3, Week 1, Week 2

• Change From Baseline in Eye Symptom Score Assessed by the Investigator

  Baseline and Day 3, Week 1, Week 2

• Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator

  Day 3, Week 1, Week 2

Study Arms (3)

Desloratadine 5 mg

EXPERIMENTAL

Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks

Drug: Desloratadine 5 mg; Drug: Placebo

Desloratadine 10 mg

EXPERIMENTAL

Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks

Drug: Desloratadine 5 mg

Placebo

PLACEBO COMPARATOR

Participants receive two placebo tablets orally once daily for up to 2 weeks

Drug: Placebo

Interventions

Desloratadine 5 mg DRUG

Desloratadine 5 mg tablets

Desloratadine 10 mg; Desloratadine 5 mg

Placebo DRUG

Matching placebo to desloratadine 5 mg tablets

Desloratadine 5 mg; Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with perennial allergic rhinitis
• Outpatient.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis; Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Immune System Diseases

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Respiratory Tract Infections; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 7, 2013
• Study Start: August 20, 2013
• Primary Completion: January 26, 2014
• Study Completion: January 26, 2014
• Last Updated: June 18, 2024
• Results First Posted: August 15, 2014

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share