NCT02246439已完成3 期
Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (The GUARD Study)
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
- 330
- 试验地点
- 26
- 主要终点
- Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population
研究概览
简要总结
Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal Release Tablets) for Acute Gastroenteritis.
The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.
详细描述
Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal Release Tablets) for Acute Gastroenteritis.
The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have vomited at least twice in the 4 hours preceding signing informed consent. A vomiting episode is defined as an episode of forceful expulsion of stomach contents. Retching if a patient has already emptied his or her gastric contents is also considered vomiting episode. A distinct episode is characterized by a clear break in vomiting activity of at least 5 minutes
- •Emesis must have been nonbloody (streaks of blood presumed due to force of retching are allowed)
- •All patients (and a parent or guardian for patients <age 18) must sign informed consent.
排除标准
- •Severe dehydration. Severe dehydration is defined as two or more of the following criteria in the presence of decreased intake and increased output due to vomiting or diarrhea: Absent or severely decreased urine output; weak pulse and/or low blood pressure; parched mucous membranes; lethargy, confusion, delirium or loss of consciousness
- •Signs and symptoms severe enough to require immediate parenteral hydration and/or parenteral antiemetic medication
- •Temperature>39.0
- •Likely etiologies for acute vomiting and diarrhea other than acute infectious or toxic gastroenteritis or gastritis. This includes signs of an acute abdomen, which may require surgical intervention
- •Chemically-induced gastroenteritis, e.g., from alcohol, other drugs of abuse or other irritant chemicals
- •Use within 24 hours of study entry of specific medication for treatment of nausea and/or vomiting, e.g., 5-HT3 antagonists or phenothiazines, or receipt of any IV fluid for any reason. Nonspecific gastrointestinal remedies, such as antacids, proton pump inhibitors and homeopathic remedies, are permitted.
- •Congestive heart failure, bradyarrhythmia (baseline pulse<55/min), known long QT syndrome
- •Patient who have known QTc prolongation > 450 msec, noted on prior or screening ECG, or who are taking medication known to cause QT prolongation. Note: for current list of medications known to cause QT prolongation see: https://www.crediblemeds.org/healthcare-providers/drug-list/ Use list showing drugs with known risk TdP.
- •Known underlying disease which could affect assessment of hydration or modify outcome of treatment, e.g., renal failure, diabetes mellitus, liver disease, alcoholism. Patients with type 2 diet-controlled diabetes mellitus whose baseline blood glucose is <200 may be entered into the study
- •Abdominal surgery within the past 3 months
- •History of bariatric surgery or bowel obstruction at any time
- •Hypersensitivity or other known intolerance to ondansetron or other 5-HT3 antagonists
- •Patient has taken apomorphine within 24 hours of screening
- •Patient has previously participated in this study
- •Patient has participated in another interventional clinical trial, for any indication, in the past 30 days
- •For women of childbearing potential: documented or possible pregnancy.
研究组 & 干预措施
RHB-102
Experimental
RHB-102, Bimodal Release Ondansetron Tablets
干预措施: RHB-102 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population
时间窗: 24 Hours
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
次要结局
- Responders Through 4 Days After First Dose of Study Medication - ITT Population(4 Days)
- Number of Participants Who Vomited - ITT Population(24 Hours)
- Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population(24 Hours)
- Number of Patients Receiving Intravenous Fluids - ITT Population(24 Hours)
- Severity of Nausea at Baseline - ITT Population(Day 1 - Baseline through 5 Hours Post Dose)
- Incidence and Severity of Diarrhea - ITT Population(From 30 Minutes Through 24 Hours after First Dose of Study Medication)
- Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population(Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last)
- Time to Resumption of Normal Activities (Work/School/Household) - ITT Population(Hours from first dose of study medication to resumption of normal activities)
- Number of Patients Requiring Hospitalization - ITT Population(Day 1 of Study - Day 5 of Study)
- Number of Patients Returning to Emergency Department - ITT Population(Day 1 of Study - Day 5 of Study)
研究者
研究点 (26)
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