Trial · NCT03633344
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
NCT03633344, Phase 2, Completed, Omnifarma Kiev LLC; results first posted 2019-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea. Trials, record NCT03633344. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03633344
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
- NCT number
- NCT03633344
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 145 participants, actual
- Lead sponsor
- Omnifarma Kiev LLC
- Conditions
- Diarrhoea;Acute
- Interventions
- Carbowhite, Carbowhite placebo
- First posted
- 2018-08-16
- Last updated
- 2019-06-06
- Results first posted
- 2019-06-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Compliance Rate | From randomisation up to 5 days | Percent of patients administered the investigational production who discontinued the study |
| Secondary | Duration of Treatment | From randomisation up to 5 days | Mean duration of treatment |
| Secondary | Quantity of Used Medication | From randomisation up to 5 days | Mean quantity of tablets per treatment course |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reduction in Frequency of Defecation to 3 Times Per Day | From randomisation up to 5 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compliance Rate | From randomisation up to 5 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Treatment | From randomisation up to 5 days | days | MEAN | |
| SECONDARY | Quantity of Used Medication | From randomisation up to 5 days | tablets | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction in Frequency of Defecation to 3 Times Per Day | Carbowhite | 118 | Participants | ||
| Reduction in Frequency of Defecation to 3 Times Per Day | Carbowhite Placebo | 24 | Participants | ||
| Compliance Rate | Carbowhite | 0 | Participants | ||
| Compliance Rate | Carbowhite Placebo | 0 | Participants | ||
| Duration of Treatment | Carbowhite | 1.7 | 95% Confidence Interval 1.6 to 1.9 | days | |
| Duration of Treatment | Carbowhite Placebo | 2.6 | 95% Confidence Interval 2.3 to 3.0 | days | |
| Quantity of Used Medication | Carbowhite | 12 | Inter-Quartile Range 12 to 24 | tablets | |
| Quantity of Used Medication | Carbowhite Placebo | 36 | Inter-Quartile Range 24 to 48 | tablets |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carbowhite | 120 | |
| Overall Study | STARTED | Carbowhite Placebo | 24 | |
| Overall Study | COMPLETED | Carbowhite | 120 | |
| Overall Study | COMPLETED | Carbowhite Placebo | 24 | |
| Overall Study | NOT COMPLETED | Carbowhite | 0 | |
| Overall Study | NOT COMPLETED | Carbowhite Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carbowhite | 0 | 120 |
| Total, all-cause mortality | Carbowhite Placebo | 0 | 24 |
| Total, other adverse events | Carbowhite | 0 | 120 |
| Total, other adverse events | Carbowhite Placebo | 0 | 24 |
| Total, serious adverse events | Carbowhite | 0 | 120 |
| Total, serious adverse events | Carbowhite Placebo | 0 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Carbowhite vs Carbowhite Placebo: Compliance Rate | Trial comparisons |
| Carbowhite vs Carbowhite Placebo: Reduction in Frequency of Defecation to 3 Times Per Day | Trial comparisons |
| Carbowhite vs Carbowhite Placebo: deaths from any cause | Trial comparisons |
| Carbowhite vs Carbowhite Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03633344
GET https://conductscience.org/api/trials/v1/NCT03633344/registered