A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Prospective Study to Evaluate the Safety and Efficacy of Domperidone in 6-month-old to 12-year-old Pediatric Subjects With Nausea and Vomiting Due to Acute Gastroenteritis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration
研究概览
简要总结
The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within the first 48 hours of treatment administration in pediatric participants with AG and mild-to-moderate dehydration.
详细描述
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), parallel-group, placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study. The study consists of 3 Phases: Screening Phase (-2 to 0 hours prior to baseline on Day 1), Double-blind treatment Phase (up to 7 Days) and follow-up Phase (7 Days). The duration of participation in the study for each participant is at most 15 Days. Efficacy and safety of domperidone will be evaluated. Participants' safety will be monitored throughout the 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant presents with at least 3 episodes of non-bilious, non-bloody vomiting within the 24 hours prior to visiting the physician's office. The participant has at least 2 signs and symptoms other than vomiting consistent with acute gastroenteritis (AG) (example, fever, nausea, diarrhea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the physician's office
- •The participant has mild-to-moderate dehydration
- •The participant had at least 1 episode of non-bloody diarrhea within the 24 hours prior to the visiting the physician's office
排除标准
- •The participant has severe dehydration or severe malnutrition
- •The participant who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline physician's office visit
- •The participant needs intravenous (IV) fluid replacement
- •The participant has chronic severe diarrhea, a previous history of Helicobacter pylori infection or received treatment for H. pylori-induced gastritis, active peptic ulcer, celiac disease, Crohn's disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery
- •The participant has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis
研究组 & 干预措施
Oral Rehydration Therapy (ORT) + Domperidone
Each participants will initiate ORT in the physician's office and domperidone 0.25 milligram per kilogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.
干预措施: Domperidone (Drug)
Oral Rehydration Therapy (ORT) + Domperidone
Each participants will initiate ORT in the physician's office and domperidone 0.25 milligram per kilogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.
干预措施: Oral Rehydration Therapy (Other)
Oral Rehydration Therapy + Placebo
Each participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.
干预措施: Oral Rehydration Therapy (Other)
Oral Rehydration Therapy + Placebo
Each participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration
时间窗: 48 Hours
The vomiting episodes will be recorded for each participants in the eDiary.
次要结局
- Number of Episodes of Nausea for Participants 4 Years of Age or Older Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration(Up to Day 7)
- Percentage of Participants Who Have No Episode of Vomiting Within the 7 Day Treatment Period After the First Treatment Administration(Day 7)
- Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the First 48 Hours of the First Treatment Administration(48 Hours)
- Number of Vomiting Episodes for Participants Within the 0 to 24 Hour, Greater Than (>) 24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration(Up to Day 7)
- Percentage of Participants who Have No Episode of Vomiting Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration(Up to Day 7)
- Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration(Up to Day 7)
- Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 7 Day Treatment Period After the First Treatment Administration(Day 7)
- Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period(Day 7)
- Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period(Day 7)
- Time to Last Study Medication Within the 7 Day Treatment Period(Day 7)
- Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period(Day 7)
- Change From Baseline in Weight at Day 2(Baseline and Day 2)
- Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration(Day 7)
- Change From Baseline in Hydration Score at Day 2(Baseline and Day 2)
- Percentage of Participants With Diarrhea Within 0 to 24 Hour, >24 to 48 Hour, >48 Hour to 7 Day, and 0 Hour to 7 Day Periods After the First Successful Treatment Administration(Up to Day 7)