Title
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.
Phase
Phase 2Lead Sponsor
Omnifarma Kiev LLCStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Diarrhoea;AcuteIntervention/Treatment
Carbowhite ...Study Participants
145The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
Background: Diarrhea is a medical condition characterized by frequent stool, more than 3 times (and more than 5-7 times in newborns) within the last 24 hours, and/or loose stool. The fecal matter is liquid, its daily mass exceeds 200 g per day, and water content reaches 95%.
Objectives: To demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
Methods: A randomized clinical trial, double-blind, placebo-controlled, multi-center.
3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
Inclusion Criteria: signed Informed Consent Form for patient's study participation male and female patients at the ages from 18 to 55 years acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or less in patients with usually normal stool body temperature of ≤ 38 °C patient's ability to adequately cooperate in the process of study Exclusion Criteria: aged of <18 or >55 years; blood or pus in stool; body temperature of >38 °C; episodes of acute diarrhea for the last 30 days; administration of antidiarrheal products for the last 24 hours; salmonellosis (Salmonella of any serotype different from S. typhi and S. paratyphi; ICD-10: A02.0), dysentery (Shigella dysenteriae, Shigella flexneri, Shigella boydii; ICD-10: A03.0-A03.3), colibacillosis (Escherichia coli; ICD-10: A04.0-A04.4) which require administration of antimicrobial products; pregnancy, lactation; concomitant decompensated diseases or acute conditions which, according to an investigator, may affect study results alcoholism and drug abuse; participation in any other clinical study.
| Event Type | Organ System | Event Term |
|---|
Percent of patients administered the investigational production who achieved the efficacy endpoint (reduction in frequency of defecation to 3 times per day, absence of loose stool) on Day 5 or earlier
Percent of patients administered the investigational production who discontinued the study
Mean duration of treatment
Mean quantity of tablets per treatment course
