Trial · NCT03447821

Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea

NCT03447821, Phase 2, Completed, Cosmo Technologies Ltd; results first posted 2018-10-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea. Trials, record NCT03447821. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03447821

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
NCT number: NCT03447821
Status: Completed
Phases: Phase 2
Enrollment: 40 participants, actual
Lead sponsor: Cosmo Technologies Ltd
Conditions: Infectious Diarrhoea
Interventions: 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage, 1200 mg Rifamycin SV dosage
First posted: 2018-02-27
Last updated: 2020-02-18
Results first posted: 2018-10-09

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Last Unformed Stool (TLUS)	Up to 7 days	The safety and preliminary efficacy data of the three doses of the new rifamycin SV formulation tested based upon the time elapsed from the ingestion of the 1st dose of study medication to the passage of the last unformed stool (TLUS)
Secondary	The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval	48 hours	The evaluation of improvement in diarrhoea during a 48 hour interval is defined as a \>50% reduction of bowel movements versus the baseline value
Secondary	The Number of Unformed Stools Passed Per 24-h Interval	192 hours	The number of unformed stools passed per 24-h interval, after dosing
Secondary	The Number of Patients Who Are Declared to be "Well"	48 hours	The patient having must meet all of the following criteria in order to be classified as "well": 48 hours with no unformed stools with a maximum of two soft stools and no clinical symptoms of infectious diarrhoea.
Secondary	Number of Participants With Treatment Failure	120 hours	A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose.
Secondary	The Number of Patients Recovered From Diarrhoea	24 hours	Patients were considered to have recovered if fewer than three unformed stools were passed in the previous 24 hours and no symptom of enteric infection were present.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Last Unformed Stool (TLUS)	Up to 7 days	Intent to Treat	hours	MEAN
SECONDARY	The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval	48 hours	Intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Unformed Stools Passed Per 24-h Interval	192 hours	ITT	Unformed stools	MEAN
SECONDARY	The Number of Patients Who Are Declared to be Well	48 hours	intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Treatment Failure	120 hours	ITT	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Number of Patients Recovered From Diarrhoea	24 hours	ITT	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group51

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Time to Last Unformed Stool (TLUS)	400 mg Rifamycin SV Dosage		59.3	Standard Deviation 12.1	hours
Time to Last Unformed Stool (TLUS)	800 mg Rifamycin SV Dosage		51.4	Standard Deviation 12.3	hours
Time to Last Unformed Stool (TLUS)	1200 mg Rifamycin SV Dosage		57.4	Standard Deviation 13.1	hours
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval	400 mg Rifamycin SV Dosage	Showed improvement within 48 hrs	4		Participants
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval	800 mg Rifamycin SV Dosage	Showed improvement within 48 hrs	9		Participants
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval	1200 mg Rifamycin SV Dosage	Showed improvement within 48 hrs	6		Participants
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval	400 mg Rifamycin SV Dosage	Showed no improvement within 48 hrs	9		Participants
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval	800 mg Rifamycin SV Dosage	Showed no improvement within 48 hrs	3		Participants
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval	1200 mg Rifamycin SV Dosage	Showed no improvement within 48 hrs	6		Participants
The Number of Unformed Stools Passed Per 24-h Interval	400 mg Rifamycin SV Dosage	0-24 h	5.23	Standard Deviation 2.74	Unformed stools

1 to 10 of 51Source ClinicalTrials.gov

See all 51 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	400 mg Rifamycin SV Dosage	14
Overall Study	STARTED	800 mg Rifamycin SV Dosage	13
Overall Study	STARTED	1200 mg Rifamycin SV Dosage	13
Overall Study	COMPLETED	400 mg Rifamycin SV Dosage	13
Overall Study	COMPLETED	800 mg Rifamycin SV Dosage	12
Overall Study	COMPLETED	1200 mg Rifamycin SV Dosage	12
Overall Study	NOT COMPLETED	400 mg Rifamycin SV Dosage	1
Overall Study	NOT COMPLETED	800 mg Rifamycin SV Dosage	1
Overall Study	NOT COMPLETED	1200 mg Rifamycin SV Dosage	1

Source ClinicalTrials.gov

Adverse events21

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	CARDIAC DISORDERS	Cardiac disorders	400 mg Rifamycin SV Dosage	0	13	0
other	CARDIAC DISORDERS	Cardiac disorders	800 mg Rifamycin SV Dosage	0	12	0
other	CARDIAC DISORDERS	Cardiac disorders	1200 mg Rifamycin SV Dosage	1	12	1
other	GASTROINTESTINAL DISORDERS	Gastrointestinal disorders	400 mg Rifamycin SV Dosage	2	13	2
other	GASTROINTESTINAL DISORDERS	Gastrointestinal disorders	800 mg Rifamycin SV Dosage	3	12	10
other	GASTROINTESTINAL DISORDERS	Gastrointestinal disorders	1200 mg Rifamycin SV Dosage	1	12	2
other	GENERAL DISORDERS	General disorders	400 mg Rifamycin SV Dosage	2	13	2
other	GENERAL DISORDERS	General disorders	800 mg Rifamycin SV Dosage	0	12	0
other	GENERAL DISORDERS	General disorders	1200 mg Rifamycin SV Dosage	0	12	0
other	PSYCHIATRIC DISORDERS	Psychiatric disorders	400 mg Rifamycin SV Dosage	1	13	1

1 to 10 of 21Source ClinicalTrials.gov

See all 21 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	400 mg Rifamycin SV Dosage	0	13
Total, all-cause mortality	800 mg Rifamycin SV Dosage	0	12
Total, all-cause mortality	1200 mg Rifamycin SV Dosage	0	12
Total, other adverse events	400 mg Rifamycin SV Dosage	4	13
Total, other adverse events	800 mg Rifamycin SV Dosage	3	12
Total, other adverse events	1200 mg Rifamycin SV Dosage	4	12
Total, serious adverse events	400 mg Rifamycin SV Dosage	0	13
Total, serious adverse events	800 mg Rifamycin SV Dosage	0	12
Total, serious adverse events	1200 mg Rifamycin SV Dosage	0	12

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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