Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
Condition: Infectious Diarrhoea
MeSH terms: Communicable Diseases; Infections; Dysentery; Diarrhea
Intervention: 400 mg Rifamycin SV dosage; 800 mg Rifamycin SV dosage; 1200 mg Rifamycin SV dosage
Intervention MeSH terms: Rifamycins; Rifamycin SV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Infectious diarrhoea; rifamycin SV; rifamycin SV MMX; MMX

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.
    

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.