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

Primary Purpose

Infectious Diarrhoea

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

400 mg Rifamycin SV dosage

800 mg Rifamycin SV dosage

1200 mg Rifamycin SV dosage

About this trial

This is an interventional treatment trial for Infectious Diarrhoea focused on measuring Infectious diarrhoea, rifamycin SV, rifamycin SV MMX, MMX

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients had to meet all of the following inclusion criteria:

Male and female patients aged 18-65 years inclusive on the date of screening.
Patients with infectious diarrhoea (ID) in the active phase of no more than 72-h duration. Criteria for diagnosis of ID were: three or more unformed stools in the preceding 24 hours, and at least one symptom of enteric infection e.g. abdominal cramps/pain, tenesmus, urgency, an excess of gas/flatulence, nausea, vomiting.
If female, and of child-bearing potential, use of an effective contraceptive method. (Oral contraceptives, injectable hormonal contraceptives, double-barrier method (condom/diaphragm with spermicide) and intra-uterine devices, according to the definition of Note 3 of ICH M3(M) Guideline. Females were considered not to be of child-bearing potential, if they were at least 12 months post-menopausal.
Ability, in the investigator's opinion to comprehend the full nature and purpose of the study, including the possible risks and side effects, and willing to comply with the requirements of the study.
Patients who have voluntarily signed and dated the informed consent document for screening and study specific procedures.
Patients must be sufficiently literate to be able to complete a diary card.

Exclusion Criteria:

Patients had not to have had of any of the following:

Females of child-bearing potential not using an effective contraceptive method.
Pregnant or lactating females.
Fever (defined as a body (axillary) temperature ≥ 38° C) present either at the screening visit or in the previous 24 hours.
Visible presence of blood in the stool at baseline.
Patients with any history or evidence on examination, of clinically significant gastrointestinal (in particular intestinal obstruction and severe intestinal ulcerative lesions), renal, hepatic, endocrine, respiratory, cardiovascular, dermatological or haematological disease, which in the opinion of the investigator could affect the interpretation of the efficacy and safety data.
Patients with moderate or severe dehydration (see Appendix 2 of the protocol, for definitions of clinical symptoms).
Prohibited previous and concomitant medication (see relevant section of the protocol).
History of recent gastrointestinal malignancy (within 6 months).
Allergy: presumptive or ascertained hypersensitivity to the study drug, history of anaphylaxis or allergic reactions in general.
History of, or current misuse of alcohol, drugs or abuse of medication.
Participation in another study with any investigational product within 3 months before screening.
Patients who, in the opinion of the investigator, could be un-cooperative and/or non-compliant and should not therefore participate in the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

400 mg Rifamycin SV dosage

800 mg Rifamycin SV dosage

1200 mg Rifamycin SV dosage

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Time to Last Unformed Stool (TLUS)

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 Outcome Measures

The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval

The evaluation of improvement in diarrhoea during a 48 hour interval is defined as a >50% reduction of bowel movements versus the baseline value

The Number of Unformed Stools Passed Per 24-h Interval

The number of unformed stools passed per 24-h interval, after dosing

The Number of Patients Who Are Declared to be "Well"

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.

Number of Participants With Treatment Failure

A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose.

The Number of Patients Recovered From Diarrhoea

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.

Full Information

NCT ID

NCT03447821

First Posted

February 9, 2018

Last Updated

February 5, 2020

Sponsor

Cosmo Technologies Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03447821

Brief Title

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

Official Title

Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea. A Pilot, Dose Finding, Double-blind, Randomized, Multicentre Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

February 2008 (Actual)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cosmo Technologies Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMXTM technology (CB-01-11) in the treatment of infectious diarrhoea. Primary end points to determine: • 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), in compliance with the relevant guidelines Secondary end-points to determine: The number of patients showing improvement in diarrhoea during a 24-h interval, i.e. >50 % reduction of bowel movements. The number of unformed stools passed per 24-h interval, after dosing. The number of patients who are declared to be "well". Wellness is defined as the patient having 48 hours with no unformed stools, a maximum of two soft stools and no clinical symptoms of infectious diarrhoea. The number of treatment failures. A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose. The number and percentage of patients recovered from diarrhoea. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infectious Diarrhoea

Keywords

Infectious diarrhoea, rifamycin SV, rifamycin SV MMX, MMX

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

400 mg Rifamycin SV dosage

Arm Type

Active Comparator

Arm 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.

Arm Title

800 mg Rifamycin SV dosage

Arm Type

Active Comparator

Arm Description

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.

Arm Title

1200 mg Rifamycin SV dosage

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

400 mg Rifamycin SV dosage

Intervention Type

Drug

Intervention Name(s)

800 mg Rifamycin SV dosage

Intervention Type

Drug

Intervention Name(s)

1200 mg Rifamycin SV dosage

Primary Outcome Measure Information:

Title

Time to Last Unformed Stool (TLUS)

Description

Time Frame

Up to 7 days

Secondary Outcome Measure Information:

Title

The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval

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

Title

The Number of Unformed Stools Passed Per 24-h Interval

Description

The number of unformed stools passed per 24-h interval, after dosing

Time Frame

192 hours

Title

The Number of Patients Who Are Declared to be "Well"

Description

Time Frame

48 hours

Title

Number of Participants With Treatment Failure

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

Title

The Number of Patients Recovered From Diarrhoea

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients had to meet all of the following inclusion criteria: Male and female patients aged 18-65 years inclusive on the date of screening. Patients with infectious diarrhoea (ID) in the active phase of no more than 72-h duration. Criteria for diagnosis of ID were: three or more unformed stools in the preceding 24 hours, and at least one symptom of enteric infection e.g. abdominal cramps/pain, tenesmus, urgency, an excess of gas/flatulence, nausea, vomiting. If female, and of child-bearing potential, use of an effective contraceptive method. (Oral contraceptives, injectable hormonal contraceptives, double-barrier method (condom/diaphragm with spermicide) and intra-uterine devices, according to the definition of Note 3 of ICH M3(M) Guideline. Females were considered not to be of child-bearing potential, if they were at least 12 months post-menopausal. Ability, in the investigator's opinion to comprehend the full nature and purpose of the study, including the possible risks and side effects, and willing to comply with the requirements of the study. Patients who have voluntarily signed and dated the informed consent document for screening and study specific procedures. Patients must be sufficiently literate to be able to complete a diary card. Exclusion Criteria: Patients had not to have had of any of the following: Females of child-bearing potential not using an effective contraceptive method. Pregnant or lactating females. Fever (defined as a body (axillary) temperature ≥ 38° C) present either at the screening visit or in the previous 24 hours. Visible presence of blood in the stool at baseline. Patients with any history or evidence on examination, of clinically significant gastrointestinal (in particular intestinal obstruction and severe intestinal ulcerative lesions), renal, hepatic, endocrine, respiratory, cardiovascular, dermatological or haematological disease, which in the opinion of the investigator could affect the interpretation of the efficacy and safety data. Patients with moderate or severe dehydration (see Appendix 2 of the protocol, for definitions of clinical symptoms). Prohibited previous and concomitant medication (see relevant section of the protocol). History of recent gastrointestinal malignancy (within 6 months). Allergy: presumptive or ascertained hypersensitivity to the study drug, history of anaphylaxis or allergic reactions in general. History of, or current misuse of alcohol, drugs or abuse of medication. Participation in another study with any investigational product within 3 months before screening. Patients who, in the opinion of the investigator, could be un-cooperative and/or non-compliant and should not therefore participate in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manuel Mancera Reyes

Organizational Affiliation

HOSPITAL CENTRAL DE ORIENTE

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Can Polat Eyigün

Organizational Affiliation

Gülhane Military Medical Academy

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

None. IPD not to be shared.

Learn more about this trial

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

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