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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

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE February 27, 2018
Results First Submitted Date  ICMJE February 28, 2018
Results First Posted Date  ICMJE October 8, 2018
Last Update Posted Date October 8, 2018
Actual Study Start Date  ICMJE February 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
Time to Last Unformed Stool (TLUS) [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03447821 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval [ Time Frame: 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
  • The Number of Unformed Stools Passed Per 24-h Interval, After Dosing [ Time Frame: 192 hours ]
    The number of unformed stools passed per 24-h interval, after dosing
  • The Number of Patients Who Are Declared to be "Well" [ Time Frame: 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.
  • The Number of Treatment Failures [ Time Frame: 120 hours ]
    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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • The number of patients showing improvement in diarrhoea during a 24-h interval [ Time Frame: 24 hours ]
    The evaluation of improvement in diarrhoea during a 24-hours interval is defined as a >50% reduction of bowel movements versus the baseline value
  • The Number of Unformed Stools Passed Per 24-h Interval, After Dosing [ Time Frame: 24 hours ]
    The number of unformed stools passed per 24-h interval, after dosing
  • The Number of Patients Who Are Declared to be "Well" [ Time Frame: 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.
  • The Number of Treatment Failures [ Time Frame: 120 hours ]
    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 [ Time Frame: 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.
  • The percentage of patients recovered from diarrhoea [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
Official Title  ICMJE Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea. A Pilot, Dose Finding, Double-blind, Randomized, Multicentre Study
Brief Summary 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 MMX technology (CB-01-11) in the treatment of infectious diarrhoea.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Infectious Diarrhoea
Intervention  ICMJE
  • Drug: 400 mg Rifamycin SV dosage
  • Drug: 800 mg Rifamycin SV dosage
  • Drug: 1200 mg Rifamycin SV dosage
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Drug: 400 mg Rifamycin SV dosage
  • Active Comparator: 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.
    Intervention: Drug: 800 mg Rifamycin SV dosage
  • Active Comparator: 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.
    Intervention: Drug: 1200 mg Rifamycin SV dosage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2018)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03447821
Other Study ID Numbers  ICMJE CB-01-11/03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: None. IPD not to be shared.
Responsible Party Cosmo Technologies Ltd
Study Sponsor  ICMJE Cosmo Technologies Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manuel Mancera Reyes HOSPITAL CENTRAL DE ORIENTE
Principal Investigator: Can Polat Eyigün Gülhane Military Medical Academy
PRS Account Cosmo Technologies Ltd
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP