Trial Outcomes & Findings for Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea (NCT NCT03447821)
NCT ID: NCT03447821
Last Updated: 2020-02-18
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 7 days
Results posted on
2020-02-18
Participant Flow
Participant milestones
| Measure |
400 mg Rifamycin SV Dosage
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
400 mg Rifamycin SV Dosage
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
Baseline characteristics by cohort
| Measure |
400 mg Rifamycin SV Dosage
n=13 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
39.6 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Height (cm)
|
165.2 cm
STANDARD_DEVIATION 9.8 • n=5 Participants
|
160.8 cm
STANDARD_DEVIATION 9.7 • n=7 Participants
|
159.1 cm
STANDARD_DEVIATION 6.2 • n=5 Participants
|
161.8 cm
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Weight (kg)
|
72.3 kg
STANDARD_DEVIATION 16.7 • n=5 Participants
|
72.9 kg
STANDARD_DEVIATION 17 • n=7 Participants
|
70.3 kg
STANDARD_DEVIATION 11.8 • n=5 Participants
|
71.8 kg
STANDARD_DEVIATION 15 • n=4 Participants
|
|
Axillary Temperature (°C)
|
36.8 Degrees Celsius
STANDARD_DEVIATION 0.5 • n=5 Participants
|
36.8 Degrees Celsius
STANDARD_DEVIATION 0.4 • n=7 Participants
|
36.7 Degrees Celsius
STANDARD_DEVIATION 0.4 • n=5 Participants
|
36.8 Degrees Celsius
STANDARD_DEVIATION 0.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 7 daysPopulation: Intent to Treat
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)
Outcome measures
| Measure |
400 mg Rifamycin SV Dosage
n=13 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
Time to Last Unformed Stool (TLUS)
|
59.3 hours
Standard Deviation 12.1
|
51.4 hours
Standard Deviation 12.3
|
57.4 hours
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Intent to treat
The evaluation of improvement in diarrhoea during a 48 hour interval is defined as a \>50% reduction of bowel movements versus the baseline value
Outcome measures
| Measure |
400 mg Rifamycin SV Dosage
n=13 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval
Showed improvement within 48 hrs
|
4 Participants
|
9 Participants
|
6 Participants
|
|
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval
Showed no improvement within 48 hrs
|
9 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 192 hoursPopulation: ITT
The number of unformed stools passed per 24-h interval, after dosing
Outcome measures
| Measure |
400 mg Rifamycin SV Dosage
n=13 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
n=11 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
The Number of Unformed Stools Passed Per 24-h Interval
144-168 h
|
3 Unformed stools
Standard Deviation 0
|
1 Unformed stools
Standard Deviation 0
|
1 Unformed stools
Standard Deviation 0
|
|
The Number of Unformed Stools Passed Per 24-h Interval
0-24 h
|
5.23 Unformed stools
Standard Deviation 2.74
|
4.67 Unformed stools
Standard Deviation 3.17
|
4.73 Unformed stools
Standard Deviation 3.41
|
|
The Number of Unformed Stools Passed Per 24-h Interval
24-48 h
|
2.15 Unformed stools
Standard Deviation 1.95
|
1.5 Unformed stools
Standard Deviation 1.57
|
2.64 Unformed stools
Standard Deviation 2.66
|
|
The Number of Unformed Stools Passed Per 24-h Interval
48-72 h
|
2.09 Unformed stools
Standard Deviation 1.64
|
1.29 Unformed stools
Standard Deviation 1.6
|
1.7 Unformed stools
Standard Deviation 1.95
|
|
The Number of Unformed Stools Passed Per 24-h Interval
72-96 h
|
1.5 Unformed stools
Standard Deviation 1.29
|
1.67 Unformed stools
Standard Deviation 2.08
|
1.8 Unformed stools
Standard Deviation 2.05
|
|
The Number of Unformed Stools Passed Per 24-h Interval
96-120 h
|
1.5 Unformed stools
Standard Deviation 0.71
|
1.5 Unformed stools
Standard Deviation 2.12
|
0.75 Unformed stools
Standard Deviation 0.96
|
|
The Number of Unformed Stools Passed Per 24-h Interval
120-144 h
|
3 Unformed stools
Standard Deviation 0
|
0.5 Unformed stools
Standard Deviation 0.71
|
1 Unformed stools
Standard Deviation 0
|
|
The Number of Unformed Stools Passed Per 24-h Interval
168-192 h
|
0 Unformed stools
Standard Deviation 0
|
1 Unformed stools
Standard Deviation 0
|
1 Unformed stools
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: intent to treat
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.
Outcome measures
| Measure |
400 mg Rifamycin SV Dosage
n=13 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
n=11 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
The Number of Patients Who Are Declared to be "Well"
Wellness Yes
|
13 Participants
|
10 Participants
|
2 Participants
|
|
The Number of Patients Who Are Declared to be "Well"
Wellness No
|
0 Participants
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 120 hoursPopulation: ITT
A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose.
Outcome measures
| Measure |
400 mg Rifamycin SV Dosage
n=13 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
n=11 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
Number of Participants With Treatment Failure
No
|
12 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants With Treatment Failure
Yes
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: ITT
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.
Outcome measures
| Measure |
400 mg Rifamycin SV Dosage
n=13 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
n=12 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
n=11 Participants
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
The Number of Patients Recovered From Diarrhoea
No
|
1 Participants
|
2 Participants
|
2 Participants
|
|
The Number of Patients Recovered From Diarrhoea
Yes
|
12 Participants
|
10 Participants
|
9 Participants
|
Adverse Events
400 mg Rifamycin SV Dosage
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
800 mg Rifamycin SV Dosage
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1200 mg Rifamycin SV Dosage
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
400 mg Rifamycin SV Dosage
n=13 participants at risk
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos.
400 mg Rifamycin SV dosage
|
800 mg Rifamycin SV Dosage
n=12 participants at risk
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos.
800 mg Rifamycin SV dosage
|
1200 mg Rifamycin SV Dosage
n=12 participants at risk
Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.
1200 mg Rifamycin SV dosage
|
|---|---|---|---|
|
Cardiac disorders
CARDIAC DISORDERS
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
15.4%
2/13 • Number of events 2
|
25.0%
3/12 • Number of events 10
|
8.3%
1/12 • Number of events 2
|
|
General disorders
GENERAL DISORDERS
|
15.4%
2/13 • Number of events 2
|
0.00%
0/12
|
0.00%
0/12
|
|
Psychiatric disorders
PSYCHIATRIC DISORDERS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL
|
0.00%
0/13
|
0.00%
0/12
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
NERVOUS SYSTEM
|
0.00%
0/13
|
0.00%
0/12
|
25.0%
3/12 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No disclosure was to take place without written authorisation from Cosmo Technologies Ltd, except to the extent necessary to obtain informed consent from potential volunteers.
- Publication restrictions are in place
Restriction type: OTHER