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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 608
- 主要终点
- Number of Participants Experiencing an Adverse Event (AE)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with perennial allergic rhinitis
- •Outpatient.
排除标准
- •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).
研究组 & 干预措施
Desloratadine 5 mg
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
干预措施: Desloratadine 5 mg (Drug)
Desloratadine 5 mg
Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
干预措施: Placebo (Drug)
Desloratadine 10 mg
Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
干预措施: Desloratadine 5 mg (Drug)
Placebo
Participants receive two placebo tablets orally once daily for up to 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing an Adverse Event (AE)
时间窗: 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
时间窗: 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 (TNSS) Assessed by the Investigator at Week 2
时间窗: 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.
次要结局
- Change From Baseline in Eye Symptom Score Reported in Participant Diaries(Baseline and Day 3, Week 1, Week 2)
- 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)
- Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator(Day 3, Week 1, Week 2)
- Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries(Baseline and Day 3, Week 1, Week 2)
- 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)
- Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator(Baseline and Day 3, Week 1, Week 2)