NCT01539304已完成3 期
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study
SamA Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period
研究概览
简要总结
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 24 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged over 24 months and under 15 years.
- •Patients who was diagnosed with perennial allergic rhinitis by ImmunoCAP test.
- •NIS mean total score of 1-week in baseline should be over 4.0.
排除标准
- •Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as pneumonia, cystic fibrosis, viral influenza, tuberculosis, asthma(status praesens).
- •Patient who has cancer, diabetes mellitus, hypertension, CNS disease, and metabolic disease which need medication.
- •Patient who has rhinitis not caused by allergy.
- •Acute or chronic sinusitis.
- •Patient who has medical history of allergy in seasonal pollen during the trial.
- •Patient who has had eyes or nose surgery within 3 months prior to the trial.
- •Patient who has had eye or upper airway infection within 1 week prior to the treatment period.
- •Beginning immunotherapy or dose of change within 1 month prior to the trial.
- •Patient who has clinical history of sensitivity to allergic rhinitis medication.
- •Patient whose heart function is abnormal: including heart failure, abnormal ECG test value that is clinically significant.
- •Patient who has experience to have participated in other clinical trial within 2 months prior to the trial.
- •Patient who has taken contraindicated medications in this study within 1 week(baseline period) prior to the treatment period.
- •For girl who had her first period, result of pregnancy test was positive.
研究组 & 干预措施
CITUS Dry Syrup
Experimental
Pranlukast dry syrup 10%
干预措施: CITUS Dry Syrup (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period
时间窗: 4 week treatment period (from baseline through the end of week 4)
Evaluation : from baseline(1-week prior to treatment)over the 4-week treatment(1-week prior to patients' last visit). NIS : Sum of 4 individual scores for Nasal congestion, Rhinorrhea, Sneezing, and Nasal itching, each rated by patients daily on a 4-point scale \[Score 0(best) to 3(worst)\].
次要结局
- Use of rescue medication(from baseline through the end of week 4)
- Assessing improvement of symptom by physician(from baseline through the end of week 4)
- Assessing improvement of symptom by patient(from baseline through the end of week 4)
- Mean change of Individual NIS(from baseline through the end of week 4)
- Ratio distribution of NIS at end of week 4(from baseline through the end of week 4)
- Cure rate(from baseline through the end of week 4)
- Cure rate for each symptom(from baseline through the end of week 4)
- Change of Instantaneous NIS(from baseline through the end of week 4)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical TrialDementia With Lewy BodiesNCT04588285Helse Fonna180
尚未招募
不适用
Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty SystemTricuspid RegurgitationNCT05173233Shanghai Huihe Medical Technology Co., Ltd67
终止
1 期
Safety, Tolerability and Pharmacokinetics of ASM-024 Administered to Healthy Subjects and Subjects With Moderate AsthmaAsthmaNCT01793298Asmacure Ltée55
已完成
不适用
Treatment of Major Depression With St. John's Wort (Hypericum)Major DepressionNCT00005013National Institute of Mental Health (NIMH)
招募中
1 期
CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic AnemiaRelapseRefractoryCAR T-cell TherapySevere Aplastic AnemiaNCT06622694Institute of Hematology & Blood Diseases Hospital, China15