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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbowhite | Active Comparator | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) |
|
| Carbowhite placebo | Placebo Comparator | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbowhite | Drug |
|
| |
| Carbowhite placebo |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oleg Kurchenko | Omnifarma Kyiv LLC | Study Director |
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In the study recruited 145 patients. One (1) of the patients dropped out of the study before being randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Carbowhite | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite |
| FG001 | Carbowhite Placebo | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carbowhite | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite |
| BG001 | Carbowhite Placebo | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | From randomisation up to 5 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carbowhite | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oleg Kurchenko | Omnifarma Kyiv LLC | +380503319653 | Kurchenko@omnifarma.kiev.ua |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 8, 2015 | Aug 27, 2018 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
|
|
| From randomisation up to 5 days |
| Quantity of Used Medication | Mean quantity of tablets per treatment course | From randomisation up to 5 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Compliance Rate | Percent of patients administered the investigational production who discontinued the study | Posted | Count of Participants | Participants | From randomisation up to 5 days |
|
|
|
| Secondary | Duration of Treatment | Mean duration of treatment | Posted | Mean | 95% Confidence Interval | days | From randomisation up to 5 days |
|
|
|
| Secondary | Quantity of Used Medication | Mean quantity of tablets per treatment course | Posted | Median | Inter-Quartile Range | tablets | From randomisation up to 5 days |
|
|
|
| 0 |
| 120 |
| 0 |
| 120 |
| 0 |
| 120 |
| EG001 | Carbowhite Placebo | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite placebo | 0 | 24 | 0 | 24 | 0 | 24 |
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