Clinical trial NCT01918033: A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 608
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2
timeFrame: Baseline and Week 2
measure: Number of Participants Experiencing an Adverse Event (AE)
timeFrame: Up to Week 4
measure: Number of Participants Discontinuing Study Drug Due to an AE
timeFrame: Up to Week 2
Secondary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1
timeFrame: Baseline and Day 3, Week 1
measure: Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator
timeFrame: Baseline and Day 3, Week 1, Week 2
measure: Change From Baseline in Nasal Finding Score Assessed by the Investigator
timeFrame: Baseline and Day 3, Week 1, Week 2
measure: Change From Baseline in Eye Symptom Score Assessed by the Investigator
timeFrame: Baseline and Day 3, Week 1, Week 2
measure: Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator
timeFrame: Day 3, Week 1, Week 2
measure: Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator
timeFrame: Baseline and Day 3, Week 1, Week 2
measure: Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries
timeFrame: Baseline and Day 3, Week 1, Week 2
measure: Change From Baseline in Eye Symptom Score Reported in Participant Diaries
timeFrame: Baseline and Day 3, Week 1, Week 2
Other outcomes:
Locations:
Study officials:
References:
citation: 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