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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01918033
First received: August 5, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Desloratadine 5 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 608
Study Start Date: August 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01918033     History of Changes
Other Study ID Numbers: 4117-200, 132244
Study First Received: August 5, 2013
Results First Received: July 24, 2014
Last Updated: July 24, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Desloratadine
Loratadine
Histamine H1 Antagonists
Cholinergic Antagonists
Neurotransmitter Agents
Histamine H1 Antagonists, Non-Sedating
Histamine Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Cholinergic Agents
Antipruritics
Dermatologic Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 18, 2014