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

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ClinicalTrials.gov Identifier: NCT03447821
Recruitment Status : Completed
First Posted : February 27, 2018
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Cosmo Technologies Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Infectious Diarrhoea
Interventions Drug: 400 mg Rifamycin SV dosage
Drug: 800 mg Rifamycin SV dosage
Drug: 1200 mg Rifamycin SV dosage
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 14 13 13
Completed 13 12 12
Not Completed 1 1 1
Reason Not Completed
Withdrawal by Subject             1             1             0
Lost to Follow-up             0             0             1
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 13 12 12 37
Hide Baseline Analysis Population Description
Intent To Treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 12 participants 37 participants
39.5  (12.1) 37.3  (15.9) 41.9  (12.7) 39.6  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 12 participants 37 participants
Female
6
  46.2%
8
  66.7%
7
  58.3%
21
  56.8%
Male
7
  53.8%
4
  33.3%
5
  41.7%
16
  43.2%
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 13 participants 12 participants 12 participants 37 participants
165.2  (9.8) 160.8  (9.7) 159.1  (6.2) 161.8  (8.9)
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 13 participants 12 participants 12 participants 37 participants
72.3  (16.7) 72.9  (17) 70.3  (11.8) 71.8  (15)
Axillary Temperature (°C)  
Mean (Standard Deviation)
Unit of measure:  Degrees Celsius
Number Analyzed 13 participants 12 participants 12 participants 37 participants
36.8  (0.5) 36.8  (0.4) 36.7  (0.4) 36.8  (0.4)
1.Primary Outcome
Title Time to Last Unformed Stool (TLUS)
Hide Description 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)
Time Frame Up to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 13 12 12
Mean (Standard Deviation)
Unit of Measure: hours
59.3  (12.1) 51.4  (12.3) 57.4  (13.1)
2.Secondary Outcome
Title The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval
Hide Description The evaluation of improvement in diarrhoea during a 48 hour interval is defined as a >50% reduction of bowel movements versus the baseline value
Time Frame 48 hours
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Hide Analysis Population Description
Intent to treat
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 13 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Showed improvement within 48 hrs
4
  30.8%
9
  75.0%
6
  50.0%
Showed no improvement within 48 hrs
9
  69.2%
3
  25.0%
6
  50.0%
3.Secondary Outcome
Title The Number of Unformed Stools Passed Per 24-h Interval, After Dosing
Hide Description The number of unformed stools passed per 24-h interval, after dosing
Time Frame 192 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 13 12 11
Mean (Standard Deviation)
Unit of Measure: Number of unformed stools
0-24 h 5.23  (2.74) 4.67  (3.17) 4.73  (3.41)
24-48 h 2.15  (1.95) 1.5  (1.57) 2.64  (2.66)
48-72 h 2.09  (1.64) 1.29  (1.6) 1.7  (1.95)
72-96 h 1.5  (1.29) 1.67  (2.08) 1.8  (2.05)
96-120 h 1.5  (0.71) 1.5  (2.12) 0.75  (0.96)
120-144 h 3  (0) 0.5  (0.71) 1  (0)
144-168 h 3  (0) 1  (0) 1  (0)
168-192 h 0  (0) 1  (0) 1  (0)
4.Secondary Outcome
Title The Number of Patients Who Are Declared to be “Well”
Hide Description 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.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 13 12 11
Measure Type: Count of Participants
Unit of Measure: Participants
Wellness Yes
13
 100.0%
10
  83.3%
2
  18.2%
Wellness No
0
   0.0%
2
  16.7%
9
  81.8%
5.Secondary Outcome
Title The Number of Treatment Failures
Hide Description A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose.
Time Frame 120 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 13 12 11
Measure Type: Count of Participants
Unit of Measure: Participants
No
12
  92.3%
10
  83.3%
9
  81.8%
Yes
1
   7.7%
2
  16.7%
2
  18.2%
6.Secondary Outcome
Title The Number of Patients Recovered From Diarrhoea
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 13 12 11
Measure Type: Count of Participants
Unit of Measure: Participants
No
1
   7.7%
2
  16.7%
2
  18.2%
Yes
12
  92.3%
10
  83.3%
9
  81.8%
Time Frame [Not Specified]
Adverse Event Reporting Description adverse events strictly reported in CRF
 
Arm/Group Title 400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Hide Arm/Group Description

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

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

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

All-Cause Mortality
400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
400 mg Rifamycin SV Dosage 800 mg Rifamycin SV Dosage 1200 mg Rifamycin SV Dosage
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/13 (30.77%)      3/12 (25.00%)      4/12 (33.33%)    
Cardiac disorders       
CARDIAC DISORDERS  1 [1]  0/13 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Gastrointestinal disorders       
GASTROINTESTINAL DISORDERS  1  2/13 (15.38%)  2 3/12 (25.00%)  10 1/12 (8.33%)  2
General disorders       
GENERAL DISORDERS  1  2/13 (15.38%)  2 0/12 (0.00%)  0 0/12 (0.00%)  0
Musculoskeletal and connective tissue disorders       
MUSCULOSKELETAL  1  0/13 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorders       
NERVOUS SYSTEM  1  0/13 (0.00%)  0 0/12 (0.00%)  0 3/12 (25.00%)  3
Psychiatric disorders       
PSYCHIATRIC DISORDERS  1  1/13 (7.69%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders       
SKIN AND SUBCUTANEOUS  1  1/13 (7.69%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
1
Term from vocabulary, MedDRA™ version 11.0
Indicates events were collected by systematic assessment
[1]
Tachycardia
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Richard Jones
Organization: Cosmo Technologies Ltd.
Phone: +353 18170370
Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT03447821     History of Changes
Other Study ID Numbers: CB-01-11/03
First Submitted: February 9, 2018
First Posted: February 27, 2018
Results First Submitted: February 28, 2018
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018