Diarrhoea;AcutePhase 2NCT03633344
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
A Phase 2 study testing Carbowhite in people with Diarrhoea;Acute, run by Omnifarma Kiev LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diarrhoea;Acute
- What is being tested?
- Carbowhite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- 29 Mar 2016to 7 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
About this study
Official title: Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.
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.
Read the 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.
- Conditions
- Diarrhoea;Acute
- Being tested
- Carbowhite, Carbowhite placebo
- Keywords
- Diarrhoea, Carbowhite, Colloidal silicon dioxide
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbowhiteDrug
Also called Colloidal Silicon Dioxide
Carbowhite placeboDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Carbowhite | Active comparator | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Receives: Drug: Carbowhite |
| Carbowhite placebo | Placebo comparator | 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) Receives: Drug: Carbowhite placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From randomisation up to 5 days
Secondary outcomes (3)
Compliance Rate
Percent of patients administered the investigational production who discontinued the study
Measured: From randomisation up to 5 days
Duration of Treatment
Mean duration of treatment
Measured: From randomisation up to 5 days
Quantity of Used Medication
Mean quantity of tablets per treatment course
Measured: From randomisation up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start29 Mar 2016
- Primary completion7 Oct 2016
- Study completion7 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diarrhoea;AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omnifarma Kiev LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oleg Kurchenko, Study director, Omnifarma Kyiv LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633344
- Sponsor's protocol ID
- CRID CODE-7-180
- Status last verified
- Aug 2018
- First submitted
- 14 Aug 2018
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.
- ClinicalTrials.gov ID
- NCT03633344
- Acronym / sponsor ID
- CRID CODE-7-180
- Conditions
- Diarrhoea;Acute
- Keywords
- Diarrhoea, Carbowhite, Colloidal silicon dioxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Omnifarma Kiev LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 7 Oct 2016 (actual)
- Study completion
- 7 Oct 2016 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbowhite | Active comparator | Drug: Carbowhite3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) |
| Carbowhite placebo | Placebo comparator | Drug: Carbowhite placebo3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbowhiteAlso: Colloidal Silicon Dioxide | Drug | Carbowhite |
| Carbowhite placeboAlso: Placebo | Drug | Carbowhite placebo |
Primary outcome
Reduction in Frequency of Defecation to 3 Times Per Day
Time frame: 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
3 secondary outcomes
Compliance Rate
Time frame: From randomisation up to 5 days
Duration of Treatment
Time frame: From randomisation up to 5 days
Quantity of Used Medication
Time frame: From randomisation up to 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oleg Kurchenko study director
Omnifarma Kyiv LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbowhite in people with Diarrhoea;Acute, run by Omnifarma Kiev LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Frequency of Defecation to 3 Times Per Day (time frame: From randomisation up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.