Diarrhoea;Acute
Conditions
Keywords
Diarrhoea, Carbowhite, Colloidal silicon dioxide
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.
Interventions
DRUGCarbowhite
DRUGCarbowhite placebo
Sponsors
Omnifarma Kiev LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Frequency of Defecation to 3 Times Per Day | 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
| Measure | Time frame | Description |
|---|---|---|
| Compliance Rate | From randomisation up to 5 days | Percent of patients administered the investigational production who discontinued the study |
| Duration of Treatment | From randomisation up to 5 days | Mean duration of treatment |
| Quantity of Used Medication | From randomisation up to 5 days | Mean quantity of tablets per treatment course |
Participant flow
Recruitment details
In the study recruited 145 patients. One (1) of the patients dropped out of the study before being randomized.
Participants by arm
| Arm | Count |
|---|---|
| Carbowhite 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
Carbowhite | 120 |
| Carbowhite Placebo 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)
Carbowhite placebo | 24 |
| Total | 144 |
Baseline characteristics
| Characteristic | Carbowhite | Carbowhite Placebo | Total |
|---|---|---|---|
| Age, Continuous | 30.9 years | 34.8 years | 31.5 years |
| Region of Enrollment Ukraine | 120 Participants | 24 Participants | 144 Participants |
| Sex: Female, Male Female | 47 Participants | 12 Participants | 59 Participants |
| Sex: Female, Male Male | 73 Participants | 12 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 24 |
| other Total, other adverse events | 0 / 120 | 0 / 24 |
| serious Total, serious adverse events | 0 / 120 | 0 / 24 |
Outcome results
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
Time frame: From randomisation up to 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carbowhite | Reduction in Frequency of Defecation to 3 Times Per Day | 118 Participants |
| Carbowhite Placebo | Reduction in Frequency of Defecation to 3 Times Per Day | 24 Participants |
Secondary
Compliance Rate
Percent of patients administered the investigational production who discontinued the study
Time frame: From randomisation up to 5 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Carbowhite | Compliance Rate | 0 Participants |
| Carbowhite Placebo | Compliance Rate | 0 Participants |
Secondary
Duration of Treatment
Mean duration of treatment
Time frame: From randomisation up to 5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Carbowhite | Duration of Treatment | 1.7 days |
| Carbowhite Placebo | Duration of Treatment | 2.6 days |
Secondary
Quantity of Used Medication
Mean quantity of tablets per treatment course
Time frame: From randomisation up to 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Carbowhite | Quantity of Used Medication | 12 tablets |
| Carbowhite Placebo | Quantity of Used Medication | 36 tablets |