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

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ClinicalTrials.gov Identifier: NCT01918033
Recruitment Status : Completed
First Posted : August 7, 2013
Results First Posted : August 15, 2014
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

August 5, 2013
August 7, 2013
July 24, 2014
August 15, 2014
April 10, 2017
August 2013
January 2014   (Final data collection date for primary outcome measure)
  • Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 [ Time Frame: Baseline and 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.
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Week 4 ]
    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.
  • Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Week 2 ]
    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.
  • Change From Baseline in Total Nasal Symptom Score Assessed by the Investigator at Week 2 [ Time Frame: Baseline, Week 2 ]
  • Percentage of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Week 4 ]
  • Percentage of Participants Discontinuing Study Treatment Due to an AE [ Time Frame: Up to Week 2 ]
Complete list of historical versions of study NCT01918033 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 [ Time Frame: Baseline and Day 3, 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.
  • Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]
    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.
  • Change From Baseline in Nasal Finding Score Assessed by the Investigator [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]
    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.
  • Change From Baseline in Eye Symptom Score Assessed by the Investigator [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]
    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.
  • Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator [ Time Frame: Day 3, Week 1, Week 2 ]
    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.
  • Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]
    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.
  • Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]
    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.
  • Change From Baseline in Eye Symptom Score Reported in Participant Diaries [ Time Frame: Baseline and Day 3, Week 1, Week 2 ]
    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.
  • Change From Baseline in Total Nasal Symptom Score Assessed by the Investiagator [ Time Frame: Baseline, Day 3, Week 1 ]
  • Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1, Week 2 ]
  • Change From Baseline in Nasal Finding Score Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1, Week 2 ]
  • Change From Baseline in Eye Symptom Score Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1, Week 2 ]
  • Percentage of Particpants With Moderate-to-Remarkable Improvement in 5 Ratings of Global Improvement Rate Assessed by the Investigator [ Time Frame: Day 3, Week 1, Week 2 ]
  • Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1, Week 2 ]
  • Change From Baseline in Nasal Symptom Score Reported in Participant Diaries [ Time Frame: Baseline, Day 3, Week 1, Week 2 ]
  • Change From Baseline in Eye Symptom Score Reported in Participant Diaries [ Time Frame: Baseline, Day 3, Week 1, Week 2 ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Perennial Allergic Rhinitis
  • Drug: Desloratadine 5 mg
    Desloratadine 5 mg tablets
  • Drug: Placebo
    Matching placebo to desloratadine 5 mg tablets
  • Experimental: Desloratadine 5 mg
    Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
    Interventions:
    • Drug: Desloratadine 5 mg
    • Drug: Placebo
  • Experimental: Desloratadine 10 mg
    Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
    Intervention: Drug: Desloratadine 5 mg
  • Placebo Comparator: Placebo
    Participants receive two placebo tablets orally once daily for up to 2 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
608
600
January 2014
January 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT01918033
4117-200
132244 ( Registry Identifier: JAPIC-CTI )
No
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP