Back to resultsEfficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Primary Purpose
Diarrhoea;Acute
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Carbowhite
Carbowhite placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhoea;Acute focused on measuring Diarrhoea, Carbowhite, Colloidal silicon dioxide
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Carbowhite
Carbowhite placebo
Arm Description
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Compliance Rate
Percent of patients administered the investigational production who discontinued the study
Duration of Treatment
Mean duration of treatment
Quantity of Used Medication
Mean quantity of tablets per treatment course
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03633344
Brief Title
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Official Title
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 29, 2016 (Actual)
Primary Completion Date
October 7, 2016 (Actual)
Study Completion Date
October 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omnifarma Kiev LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea;Acute
Keywords
Diarrhoea, Carbowhite, Colloidal silicon dioxide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbowhite
Arm Type
Active Comparator
Arm Description
3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
Arm Title
Carbowhite placebo
Arm Type
Placebo Comparator
Arm Description
3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
Intervention Type
Drug
Intervention Name(s)
Carbowhite
Other Intervention Name(s)
Colloidal Silicon Dioxide
Intervention Type
Drug
Intervention Name(s)
Carbowhite placebo
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Reduction in Frequency of Defecation to 3 Times Per Day
Description
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
Time Frame
From randomisation up to 5 days
Secondary Outcome Measure Information:
Title
Compliance Rate
Description
Percent of patients administered the investigational production who discontinued the study
Time Frame
From randomisation up to 5 days
Title
Duration of Treatment
Description
Mean duration of treatment
Time Frame
From randomisation up to 5 days
Title
Quantity of Used Medication
Description
Mean quantity of tablets per treatment course
Time Frame
From randomisation up to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleg Kurchenko
Organizational Affiliation
Omnifarma Kyiv LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
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