Trial Outcomes & Findings for Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea (NCT NCT03633344)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

145 participants

Primary outcome timeframe

From randomisation up to 5 days

Results posted on

2019-06-06

Participant Flow

In the study recruited 145 patients. One (1) of the patients dropped out of the study before being randomized.

Participant milestones

Participant milestones
Measure	Carbowhite 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite	Carbowhite Placebo 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite placebo
Overall Study STARTED	120	24
Overall Study COMPLETED	120	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carbowhite n=120 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite	Carbowhite Placebo n=24 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite placebo	Total n=144 Participants Total of all reporting groups
Region of Enrollment Ukraine	120 Participants n=99 Participants	24 Participants n=107 Participants	144 Participants n=206 Participants
Age, Continuous	30.9 years n=99 Participants	34.8 years n=107 Participants	31.5 years n=206 Participants
Sex: Female, Male Female	47 Participants n=99 Participants	12 Participants n=107 Participants	59 Participants n=206 Participants
Sex: Female, Male Male	73 Participants n=99 Participants	12 Participants n=107 Participants	85 Participants n=206 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Carbowhite n=120 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite	Carbowhite Placebo n=24 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) t.i.d. (630 mg х 3 = 1,890 mg)
Reduction in Frequency of Defecation to 3 Times Per Day	118 Participants	24 Participants

SECONDARY outcome

Timeframe: From randomisation up to 5 days

Percent of patients administered the investigational production who discontinued the study

Outcome measures

Outcome measures
Measure	Carbowhite n=120 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite	Carbowhite Placebo n=24 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) t.i.d. (630 mg х 3 = 1,890 mg)
Compliance Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomisation up to 5 days

Mean duration of treatment

Outcome measures

Outcome measures
Measure	Carbowhite n=120 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite	Carbowhite Placebo n=24 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) t.i.d. (630 mg х 3 = 1,890 mg)
Duration of Treatment	1.7 days Interval 1.6 to 1.9	2.6 days Interval 2.3 to 3.0

SECONDARY outcome

Timeframe: From randomisation up to 5 days

Mean quantity of tablets per treatment course

Outcome measures

Outcome measures
Measure	Carbowhite n=120 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Carbowhite	Carbowhite Placebo n=24 Participants 3 tablets as a single dose (210 mg х 3 = 630 mg) t.i.d. (630 mg х 3 = 1,890 mg)
Quantity of Used Medication	12 tablets Interval 12.0 to 24.0	36 tablets Interval 24.0 to 48.0

Adverse Events

Carbowhite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carbowhite Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Oleg Kurchenko

Omnifarma Kyiv LLC

Phone: +380503319653

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place