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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diarrhoea;Acute
Interventions Drug: Carbowhite
Drug: Carbowhite placebo
Enrollment 145
Recruitment Details In the study recruited 145 patients. One (1) of the patients dropped out of the study before being randomized.
Pre-assignment Details  
Arm/Group Title Carbowhite Carbowhite Placebo
Hide Arm/Group Description

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite placebo

Period Title: Overall Study
Started 120 24
Completed 120 24
Not Completed 0 0
Arm/Group Title Carbowhite Carbowhite Placebo Total
Hide Arm/Group Description

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite placebo

Total of all reporting groups
Overall Number of Baseline Participants 120 24 144
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 120 participants 24 participants 144 participants
30.9
(22.9 to 35.0)
34.8
(23.9 to 47.6)
31.5
(23.5 to 35.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 24 participants 144 participants
Female
47
  39.2%
12
  50.0%
59
  41.0%
Male
73
  60.8%
12
  50.0%
85
  59.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Ukraine Number Analyzed 120 participants 24 participants 144 participants
120
 100.0%
24
 100.0%
144
 100.0%
1.Primary Outcome
Title Reduction in Frequency of Defecation to 3 Times Per Day
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbowhite Carbowhite Placebo
Hide Arm/Group Description:

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite

3 tablets as a single dose (210 mg х 3 = 630 mg) t.i.d. (630 mg х 3 = 1,890 mg)
Overall Number of Participants Analyzed 120 24
Measure Type: Count of Participants
Unit of Measure: Participants
118
  98.3%
24
 100.0%
2.Secondary Outcome
Title Compliance Rate
Hide Description Percent of patients administered the investigational production who discontinued the study
Time Frame From randomisation up to 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbowhite Carbowhite Placebo
Hide Arm/Group Description:

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite placebo

Overall Number of Participants Analyzed 120 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Duration of Treatment
Hide Description Mean duration of treatment
Time Frame From randomisation up to 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbowhite Carbowhite Placebo
Hide Arm/Group Description:

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite placebo

Overall Number of Participants Analyzed 120 24
Mean (95% Confidence Interval)
Unit of Measure: days
1.7
(1.6 to 1.9)
2.6
(2.3 to 3.0)
4.Secondary Outcome
Title Quantity of Used Medication
Hide Description Mean quantity of tablets per treatment course
Time Frame From randomisation up to 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carbowhite Carbowhite Placebo
Hide Arm/Group Description:

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite

3 tablets as a single dose (210mg х 3 = 630 mg) t.i.d. (630 mg х 3 = 1,890 mg);
Overall Number of Participants Analyzed 120 24
Median (Inter-Quartile Range)
Unit of Measure: tablets
12
(12 to 24)
36
(24 to 48)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carbowhite Carbowhite Placebo
Hide Arm/Group Description

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite placebo

All-Cause Mortality
Carbowhite Carbowhite Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Carbowhite Carbowhite Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carbowhite Carbowhite Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/120 (0.00%)   0/24 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Oleg Kurchenko
Organization: Omnifarma Kyiv LLC
Phone: +380503319653
EMail: Kurchenko@omnifarma.kiev.ua
Layout table for additonal information
Responsible Party: Omnifarma Kiev LLC
ClinicalTrials.gov Identifier: NCT03633344     History of Changes
Other Study ID Numbers: CRID CODE-7-180
First Submitted: August 14, 2018
First Posted: August 16, 2018
Results First Submitted: August 29, 2018
Results First Posted: June 6, 2019
Last Update Posted: June 6, 2019