Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea

Diarrhoea;Acute Clinical Trial

Official title:

Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633344
• Other study ID #: CRID CODE-7-180
• Status: Completed
• Phase: Phase 2
• Start date: March 29, 2016
• Est. completion date: October 7, 2016

Study information

• Verified date: August 2018
• Source: Omnifarma Kiev LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 7, 2016
• Est. primary completion date: October 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Diarrhoea;Acute

Intervention

Drug:
• Carbowhite

• Carbowhite placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Omnifarma Kiev LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Frequency of Defecation to 3 Times Per Day	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	From randomisation up to 5 days
Secondary	Compliance Rate	Percent of patients administered the investigational production who discontinued the study	From randomisation up to 5 days
Secondary	Duration of Treatment	Mean duration of treatment	From randomisation up to 5 days
Secondary	Quantity of Used Medication	Mean quantity of tablets per treatment course	From randomisation up to 5 days