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

NCT03633344 | Completed Phase 2 Results DMC

• 1 other identifier: CRID CODE-7-180
• Study Type: interventional
• Target: 145
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diarrhoea;Acute

Keywords

Diarrhoea; Carbowhite; Colloidal silicon dioxide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Compliance Rate

  From randomisation up to 5 days

• Duration of Treatment

  From randomisation up to 5 days

• Quantity of Used Medication

  From randomisation up to 5 days

Study Arms (2)

Carbowhite

ACTIVE COMPARATOR

3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

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)

Drug: Carbowhite placebo

Interventions

Carbowhite DRUG

Also known as: Colloidal Silicon Dioxide

Carbowhite

Carbowhite placebo DRUG

Also known as: Placebo

Carbowhite placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Omnifarma Kiev LLC: lead

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Oleg Kurchenko
• Organization: Omnifarma Kyiv LLC

Kurchenko@omnifarma.kiev.ua

+380503319653

Study Officials

• Oleg Kurchenko

  Omnifarma Kyiv LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 16, 2018
• Study Start: March 29, 2016
• Primary Completion: October 7, 2016
• Study Completion: October 7, 2016
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share