CTRI/2025/11/097325尚未招募不适用
A Prospective, Randomized, Multicenter, Double-blind, Parallel-group, Placebo-controlled Study to Compare Efficacy and Safety of Dioctahedral Smectite Plus Sachets versus Placebo Sachets in Treatment of Subjects with Acute Diarrhea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Time to recovery, defined as time from the 1st study treatment intake to the first formed stool followed by a
研究概览
简要总结
Prospective, Randomized, Multicenter, Double-blind, Parallel-group, Placebo-controlled Study to Compare Efficacy and Safety of Dioctahedral Smectite Plus Sachets versus Placebo Sachets in Treatment of Subjects with Acute Diarrhea
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •A subject must fulfill all of the inclusion criteria to be enrolled in the study
- •Male and females between 18-65 years (both ages inclusive)
- •Subject has a diagnosis of acute diarrhea presumed of infectious origin, defined as The passage of 3 or more unformed loose or watery stools (rated according to the Bristol scale) per day without associated alarm symptoms marked with asterisk in the exclusion criteria Having started within 48 hours before Visit 1 (first study drug intake time).
- •Subject has, usually, normal bowel habits, (Rome III criteria), that is at least 3 stools per week and no more than 3 stools per day
- •Subjects willing and able to comply to protocol-defined study procedures
- •Subjects willing to voluntarily give their written informed consent to participate in the study Symptoms considered as alarm symptoms are identified in the exclusion criteria (1) Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC.
- •Functional Bowel Disorders.
- •Gastroenterology 2006,131:1480 91.
排除标准
- •subject must not fulfill any exclusion criteria to be enrolled in the study: Exclusion related to acute diarrhea episode
- •At least one of the following alarm symptoms as per ROME III criteria i).
- •Bloody diarrhea ii).
- •Pus in the stools iii).
- •Fever grater than or equal to 38.0 degree celsius (That is grater than or equal to 100.4 degree fahrenheit) iv).
- •Moderate or severe dehydration according to World Health Organisation (WHO) definition, requiring intravenous (IV) rehydration, v).
- •Repeated vomiting vi).
- •Persistent abdominal pain These symptoms are considered as alarm symptoms
- •Other episode of acute watery diarrhea within the previous 30 days,
- •Persistent diarrhea, defined as acutely starting episode of diarrhea lasting more than 14 days
- •History of chronic diarrhea (Rome III criteria); i.e. 3 or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months
- •Travellers diarrhea defined as a diarrheal episode due to contamination experienced by subjects having travelled in at risk countries, or coming from abroad and experiencing locally an acute diarrhea episode, occurring usually within the first 2 weeks of the stay in a foreign environment.
- •Diarrhea suspected to be induced by any medication drug (example antibiotic therapy, including Clostridium difficile-induced diarrhea, within 1 week before entry in the study, laxative agent, thyroid hormone (at a nonstabilised dosing), colchicine intake, etc.)
- •Anti-diarrheal medication intake during the last month or currently on medication which is known to cause diarrhea
- •Any subject requiring repeated intake of a drug with a narrow therapeutic margin (for example, digoxin, theophylline, etc.)
- •Subject currently receiving or and in the opinion of the investigator likely to require treatment during the study with drugs that are not permitted by the study protocol (for example, antibiotic agents, anti-diarrheal agents, antiemetic drug, antispasmodic drug, etc.) during the study
- •Subjects use of any investigational medication or participation in the clinical trial within the last 30 days before entering this study
- •History of gastric or intestinal resection, or vagotomy
- •Known digestive malabsorption disease, including coeliac disease
- •Any suspicion of abdominal surgery needed during study period
- •Known inflammatory bowel disease.
- •Known or suspected immunosuppression
- •Known severe renal or hepatic insufficiency
- •History of, or known current, problems with alcohol abuse and or known drug addict),
- •Have participated in any other clinical trial within 1 month prior to screening visit
- •Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and or evidence of an uncooperative attitude
- •Pregnant or lactating women.
- •Female of childbearing potential not willing to use adequate and consistent method of contraception during entire study period
- •Any clinically significant medical and or surgical condition or a laboratory abnormality that, in the opinion of the investigator, would put the subject at risk through study period, or would affect the study analyses or protocol compliance if the disease exacerbates during the study; and would make the subject unsuitable to be enrolled in the study as per investigators opinion.
结局指标
主要结局
Time to recovery, defined as time from the 1st study treatment intake to the first formed stool followed by a
时间窗: Day 5, day 9 from study treatment dispense
non watery stool. Consistency will be rated according to the Bristol scale. (Test product versus Placebo)
时间窗: Day 5, day 9 from study treatment dispense
次要结局
- Secondary Efficacy Endpoints(Abdominal pain intensity (rated with a 4-point ordinal scale 1 is equal to mild, 2 is equal to moderate, 3 is equal to severe, 4 is equal to very severe) per 12hour period after 1st study treatment intake)
研究者
Dr Ashish Mungantiwar
Macleods Pharmaceuticals
研究点 (3)
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