A Phase III, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 449
- 主要终点
- Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy
研究概览
简要总结
This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to placebo.
详细描述
This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms
- •Male or female who is unlikely to conceive: a surgically sterilized female, female who has reached natural menopause, or is of reproductive potential and agrees to either remain abstinent or use (or have her partner use) 2 acceptable methods of birth control from study start through 14 days after the last dose of study drug.
排除标准
- •Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment
- •Has a coexisting infection or systemic mycosis for which there are no effective antibiotics
- •Has asthma that is under treatment and/or uncontrolled
- •Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed
- •Has vasomotor rhinitis or eosinophilic rhinitis
- •Has a history of hypersensitivity to antihistamines or ingredients of study drug
- •Has had treatment with corticosteroids (oral, injectable, suppository, depot drugs [injectable]) or immunological drugs within 28 days prior to Visit 2
- •Is currently receiving treatment with another investigational drug or has received an investigational drug within prior 3 months
- •Has started specific desensitization therapy (allergen immunotherapy) or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who has received such therapies within prior 3 months
- •Has received coagulation or resection using laser therapy etc. for treatment for nasal symptoms
- •Will receive nasal nebulizer therapy and/or thermotherapy during study period
- •Has severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
- •Has a history of malignancy or clinically important hematological disorder, except for adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix
- •Has a history of severe drug allergy (e.g. anaphylactoid reaction)
- •Is pregnant or lactating or may be pregnant
- •Is planning a remote trip for more than 1 day during the Symptom Confirmation Period or for more than 2 days during the Treatment Period.
研究组 & 干预措施
Desloratadine
After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period.
干预措施: Desloratadine 5 mg (Drug)
Placebo
After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy
时间窗: Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment
The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), rhinorrhea (daily frequency of blowing nose scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), nasal congestion (scored from 0 \[no nasal blockage\] to 4 \[completely obstructed all day\]), and nasal itching (scored from 0 \[none\] to 4 \[nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement.
Number of Participants Who Discontinue Study Drug Due to an AE
时间窗: Up to 2 weeks
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
Number of Participants Who Experience at Least One Adverse Event (AE)
时间窗: Up to 4 weeks (Up to 2 weeks after last dose of study drug)
An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.
次要结局
- Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy(Baseline, Day 1 to Day 13 (Weeks 1 through 2 average))
- Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy(Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment)
- Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed Participants at Week 2(From Baseline to Week 2)
- Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)(Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment)
- Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)(Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment)
- Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment(Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment)
- Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)(Baseline, Day 8 to 13 (Week 2) of double-blind treatment)
- Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)(Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment)
- Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy(Baseline, Day 1 to Day 13 (Weeks 1 through 2 average))
- Percentage of Participants With Impression Assessments of "Better" or "Much Better" as Assessed by the Investigator at Week 2(From Baseline to Week 2)