A Randomized, Double Blind, Parallel Group Study for Assessing the Efficacy and Safety of a Twice-daily Fexofenadine HCl 60 mg - Pseudoephedrine HCl 60 mg Combination or Fexofenadine HCl 60 mg - Pseudoephedrine HCl 120 mg Combination Versus Allegra® 60 mg in Patients With Seasonal Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 520
- 试验地点
- 3
- 主要终点
- Changes in the nasal congestion score based on the patient's symptom diary
研究概览
简要总结
Primary Objective:
- To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60) in patients with seasonal allergic rhinitis (SAR).
Secondary Objectives:
- To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment.
- To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.
详细描述
The study duration for each patient is 3 weeks and 3 days:
- Lead-in period: 1 week
- Treatment period: 2 weeks
- Follow-up period: 3 days
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, Care Provider)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
FEX 60 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)
Double-blind treatment period:
1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination)
干预措施: fexofenadine HCL (M016455) (Drug)
FEX 60 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)
Double-blind treatment period:
1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination)
干预措施: pseudoephedrine (Drug)
FEX 60 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)
Double-blind treatment period:
1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination)
干预措施: fexofenadine HCL matching placebo (Drug)
FEX 60 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)
Double-blind treatment period:
1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination)
干预措施: pseudoephedrine matching placebo (Drug)
FEX 60 mg/PSE 60 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination
Double-blind treatment period:
1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination)
干预措施: fexofenadine HCL (M016455) (Drug)
FEX 60 mg/PSE 60 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination
Double-blind treatment period:
1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination)
干预措施: pseudoephedrine (Drug)
FEX 60 mg/PSE 60 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination
Double-blind treatment period:
1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination)
干预措施: fexofenadine HCL matching placebo (Drug)
FEX 60 mg/PSE 60 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination
Double-blind treatment period:
1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination)
干预措施: pseudoephedrine matching placebo (Drug)
FEX 60 mg/PSE 120 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)
Double-blind treatment period:
2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg
干预措施: fexofenadine HCL (M016455) (Drug)
FEX 60 mg/PSE 120 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)
Double-blind treatment period:
2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg
干预措施: pseudoephedrine (Drug)
FEX 60 mg/PSE 120 mg
Study medications is administered one hour before or two hours after a meal twice a day.
Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination)
Double-blind treatment period:
2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg
干预措施: fexofenadine HCL matching placebo (Drug)
结局指标
主要结局
Changes in the nasal congestion score based on the patient's symptom diary
时间窗: over 2 treatment weeks (from baseline to end of treatment)
次要结局
- Changes in total score of 4 symptoms on a daily, day-time, and night-time bases(over 2 treatment weeks (from baseline to end of treatment))
- Patient's impression(over 2 treatment weeks (from baseline to end of treatment))
- Patient's safety(over 2 treatment weeks (from baseline to end of treatment))
- Changes in the total score of 4 symptoms, each nasal symptom (sneezing, rhinorrhea, and nasal congestion) and eye symptom(over 2 treatment weeks (from baseline to end of treatment))
- Nasal findings(over 2 treatment weeks (from baseline to end of treatment))
- Changes in each symptom (sneezing, rhinorrhea, nasal congestion, and eye symptoms) score and the daily activity impairment score(over 2 treatment weeks (from baseline to end of treatment))
- Changes in each symptom score and the daily activity impairment score on a daily, day-time and night-time basis(over 2 treatment weeks (from baseline to end of treatment))