A double blind, randomized, placebo controlled, parallel group, three arm, multicenter and multinational pivotal study to assess the efficacy and safety of two dosage regimens of Crofelemer tablets in the treatment of moderate to severe acute watery diarrhea in adult patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 717
- 试验地点
- 14
- 主要终点
- To compare the difference in the mean stool output in grams/kg of bodyweight between placebo and any of the two active treatment groups
研究概览
简要总结
This is a randomized, double-blind, placebo controlled, parallel group, three arms, pivotal study. The study will be conducted in hospitalized adult patients with a moderate to severe acute watery diarrhea. A total of 717 patients will be enrolled across the multicenter from India and Bangladesh. Patients will be recruited after obtaining written informed consent. After screening and rehydration for four hours, patients with adequate hydration, will be randomized in 1:1:1 ratio to receive either one of the two dose regimens of Crofelemer or placebo. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary objective of the study is to compare the difference in the mean stool output in grams/kg of bodyweight between Placebo and any of the two active treatment groups after the first dose of the Investigational Product at 0 hours to the end of the first 12 hours post dose. Secondary objectives of the study are: to compare the stool output in grams/kg bodyweight at 24 hours post dose and till recovery, to compare the mean frequency of diarrhea post dose, to compare the mean total volume of oral and or parenteral fluid rehydration from the start of treatment till the end of 48 hours and to evaluate the safety of the Investigational Product.
Patient will be followed for safety and efficacy at every 6 hours after IP administration till 48 hours then after at every 24 hours till discharge. There will be a follow-up visit at day 10 after the discharge.
As per DCGI direction, electolyte balance and incidence of occurance of hypertension will be monitored in placebo group during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patient ≥18 to ≤65 years.
- •Clinical history of ≥3 episodes of acute watery diarrhea.
- •Moderate to severe diarrhea based on functional impairment.
- •Able to comprehend and provide written informed consent for participating in the study, or if in case, the subject is not in the condition to provide written informed consent, consent from Legally Acceptable Representative (LAR) is acceptable.
- •Women of childbearing age or potential using adequate contraceptive measures or have been documented to be post menopausal through history taking or having been diagnosed as non pregnant by means of a Urine Pregnancy Test before randomization.
排除标准
- •History of receiving antimicrobial or anti diarrheal medication within 6 hours prior to administration of the Investigational Product.
- •Patients who have participated in any other interventional clinical trial within the preceding 3 months prior to enrollment in this study.
- •Patients with history of significant cardiac, hepatic, renal, cerebrovascular disease and/or other serious illnesses.
- •Any other condition which the Investigator feels will pose a significant hazard to the subject if the Investigational Product were to be administered.
结局指标
主要结局
To compare the difference in the mean stool output in grams/kg of bodyweight between placebo and any of the two active treatment groups
时间窗: 12 hours
次要结局
- To compare the stool output in grams/kg bodyweight(24 hours)
- To compare the mean frequency of diarrhea from baseline(12 hours & 24 hours)
- To compare the mean total volume of oral and or parenteral fluid rehydration(48 hours)
- To evaluate the safety of the Investigational Product based on the occurrence of treatment emergent adverse events, clinically significant abnormal laboratory test values and vital signs.(10 days)