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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633344
Recruitment Status : Completed
First Posted : August 16, 2018
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Omnifarma Kiev LLC

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.

Condition or disease Intervention/treatment Phase
Diarrhoea;Acute Drug: Carbowhite Drug: Carbowhite placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.
Actual Study Start Date : March 29, 2016
Actual Primary Completion Date : October 7, 2016
Actual Study Completion Date : October 7, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. Reduction in Frequency of Defecation to 3 Times Per Day [ Time Frame: From randomisation up to 5 days ]
    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 :
  1. Compliance Rate [ Time Frame: From randomisation up to 5 days ]
    Percent of patients administered the investigational production who discontinued the study

  2. Duration of Treatment [ Time Frame: From randomisation up to 5 days ]
    Mean duration of treatment

  3. Quantity of Used Medication [ Time Frame: From randomisation up to 5 days ]
    Mean quantity of tablets per treatment course



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633344


Sponsors and Collaborators
Omnifarma Kiev LLC
Investigators
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Study Director: Oleg Kurchenko Omnifarma Kyiv LLC
  Study Documents (Full-Text)

Documents provided by Omnifarma Kiev LLC:

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Responsible Party: Omnifarma Kiev LLC
ClinicalTrials.gov Identifier: NCT03633344     History of Changes
Other Study ID Numbers: CRID CODE-7-180
First Posted: August 16, 2018    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Omnifarma Kiev LLC:
Diarrhoea
Carbowhite
Colloidal silicon dioxide
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Silicon
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs