NCT02498509已完成3 期
A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Concomitant Mometasone Furoate and Levocabastine HCl in Perennial Allergic Rhinitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- change in rTNSS from baseline
研究概览
简要总结
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
详细描述
A Randomized, Double-blind, Active-controlled, Multicenter phase 3 Clinical trial to evaluate the Efficacy and Safety of Concomitant Mometasone furoate and Levocabastine HCl in Perennial Allergic Rhinitis patients
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male, female, Age: over 13 years(no age limiation in upper)
- •subject who has experienced perennial allergic rhinitis for over 1 year
- •subject who has identified allergens throughout the year within 12 months
- •subject who has the symptoms of moderate to severe allergic rhinitis
- •subject who can record the the patient diary during the clinical trial period
- •subject who agreed to keep the same environment during the clinical trial period
排除标准
- •Previous medical history at screening (Nasal polyps within the previous two months, biopsies, ulcers, trauma, surgery, atrophic rhinitis, patients with a history of drug rhinitis)
- •Patients with untreated localized infection in nasal mucosa
- •Patients following administration of a combination of prohibited drugs in patients administered concomitant medications or trial period is expected to be inevitable
- •Patients with abnormal following laboratory test results at screening
- •AST, ALT>2times the upper limit of normal at screening
- •Serum creatinine >1.5times the upper limit of normal at screening
- •Previous history of acute or severe chronic sinusitis within 30 days at screening
- •The continue use of drugs that may affect the efficacy of the Investigational product
- •Start the immunotherapy or a change of doge within 1 month, at screening
- •If you have glaucoma or cataracts, herpes simplex, or around the eyes
- •Chronic obstructive pulmonary disease (COPD)
- •history of hypersensitivity reactions and for treaties or major components of the IP
- •Pregnant women, breast feeding women or women of childbearing potential must agree to use appropriate contraception methods
- •Alcohol or illegal drug abuse or dependence in patients
- •participation in any investigational or maketed drug within 4weeks preceding the screening visit
- •Patients that can not be participating in a clinical trial by investigator's discretion
研究组 & 干预措施
Treatment
Experimental
CKD-342
干预措施: CKD-342 (Drug)
Control 1
Active Comparator
Mometasone furoate
干预措施: Mometasone furoate (Drug)
Control 2
Active Comparator
Levocabastine HCL
干预措施: Levocabastine HCL (Drug)
结局指标
主要结局
change in rTNSS from baseline
时间窗: up to week 4
次要结局
- change in AM rTNSS and PM rTNSS from baseline(2 weeks and 4 weeks after the baseline assessment)
- change from baseline in RQLQ(2 weeks and 4 weeks after the baseline assessment)
- change in rTNSS from baseline(up to week 2)
- Physician assessed overall nasal symptom from baseline(2 weeks and 4 weeks after the basline assessment)
- Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline(2 weeks and 4 weeks after the basline assessment)
研究者
研究点 (1)
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