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: February 6, 2014
Last verified: February 2014
  Purpose

This is a study to evaluate the efficacy and safety of desloratadine 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 10 mg
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 Assessed by the Investigator at Week 2 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Week 4 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Discontinuing Study Treatment Due to an AE [ Time Frame: Up to Week 2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Total Nasal Symptom Score Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1 ] [ Designated as safety issue: No ]
  • Change From Baseline in Nasal Symptom Sub-Score Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1, Week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Nasal Finding Score Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1, Week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Eye Symptom Score Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1, Week 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Moderate-to-Remarkable Improvement in 5 Ratings of Global Improvement Rate Assessed by the Investigator [ Time Frame: Day 3, Week 1, Week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator [ Time Frame: Baseline, Day 3, Week 1, Week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Nasal Symptom Score Reported in Participant Diaries [ Time Frame: Baseline, Day 3, Week 1, Week 2 ] [ Designated as safety issue: No ]
  • Change From Baseline in Eye Symptom Score Reported in Participant Diaries [ Time Frame: Baseline, Day 3, Week 1, Week 2 ] [ Designated as safety issue: No ]

Estimated 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 10 mg
Desloratadine 10 mg administered orally once daily for up to 2 weeks.
Drug: Desloratadine 10 mg
Desloratadine 10 mg once daily for up to 2 weeks.
Other Name: MK-4117
Experimental: Desloratadine 5 mg
Desloratadine 5 mg administered orally once daily for up to 2 weeks.
Drug: Desloratadine 5 mg
Desloratadine 5 mg once daily for up to 2 weeks.
Other Name: MK-4117
Placebo Comparator: Placebo
Matching placebo to desloratadine administered orally once daily.
Drug: Placebo
Matching placebo to desloratadine once daily for up to 2 weeks.

  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:

  • Participants with lower respiratory tract infection and participants who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.)
  • History of hypersensitivity to antihistamines or study drug;
  Contacts and Locations
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, MK-4117-200, 132244
Study First Received: August 5, 2013
Last Updated: February 6, 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 April 15, 2014