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.

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.

Study Overview

• Status: Completed
• Conditions: Diarrhoea;Acute
• Intervention / Treatment: Drug: Carbowhite; Drug: Carbowhite placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Carbowhite; 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)	Drug: Carbowhite; Other Names: Colloidal Silicon Dioxide
Placebo Comparator: Carbowhite placebo; 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)	Drug: Carbowhite placebo; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance Rate	Percent of patients administered the investigational production who discontinued the study	From randomisation up to 5 days
Duration of Treatment	Mean duration of treatment	From randomisation up to 5 days
Quantity of Used Medication	Mean quantity of tablets per treatment course	From randomisation up to 5 days

Collaborators and Investigators

• Sponsor: Omnifarma Kiev LLC
• Investigators: Study Director: Oleg Kurchenko, Omnifarma Kyiv LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2016
• Primary Completion (Actual): October 7, 2016
• Study Completion (Actual): October 7, 2016

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Diarrhoea; Carbowhite; Colloidal silicon dioxide
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: CRID CODE-7-180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No