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

NCT03447821 | Completed Phase 2 Results

• 1 other identifier: CB-01-11/03
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infectious Diarrhoea

Keywords

Infectious diarrhoea; rifamycin SV; rifamycin SV MMX; MMX

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to 7 days

Secondary Outcomes (5)

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

  48 hours

• The Number of Unformed Stools Passed Per 24-h Interval

  192 hours

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

  48 hours

• Number of Participants With Treatment Failure

  120 hours

• The Number of Patients Recovered From Diarrhoea

  24 hours

Study Arms (3)

400 mg Rifamycin SV dosage

ACTIVE COMPARATOR

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.

Drug: 400 mg Rifamycin SV dosage

800 mg Rifamycin SV dosage

ACTIVE COMPARATOR

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.

Drug: 800 mg Rifamycin SV dosage

1200 mg Rifamycin SV dosage

ACTIVE COMPARATOR

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.

Drug: 1200 mg Rifamycin SV dosage

Interventions

400 mg Rifamycin SV dosage DRUG

400 mg Rifamycin SV dosage

800 mg Rifamycin SV dosage DRUG

800 mg Rifamycin SV dosage

1200 mg Rifamycin SV dosage DRUG

1200 mg Rifamycin SV dosage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cosmo Technologies Ltd: lead

MeSH Terms

Conditions

Dysentery

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Richard Jones
• Organization: Cosmo Technologies Ltd.

RJones@cosmopharma.com

+353 18170370

Study Officials

• Manuel Mancera Reyes

  HOSPITAL CENTRAL DE ORIENTE

  PRINCIPAL INVESTIGATOR

• Can Polat Eyigün

  Gülhane Military Medical Academy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 27, 2018
• Study Start: February 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 18, 2020
• Results First Posted: October 9, 2018

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share