Infectious DiarrhoeaPhase 2NCT03447821
Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
A Phase 2 study testing 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage and 1200 mg Rifamycin SV dosage in people with Infectious Diarrhoea, run by Cosmo Technologies Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infectious Diarrhoea
- What is being tested?
- 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage and 1200 mg Rifamycin SV dosage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea. A Pilot, Dose Finding, Double-blind, Randomized, Multicentre Study
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.
Read the 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.
- Conditions
- Infectious Diarrhoea
- Being tested
- 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage, 1200 mg Rifamycin SV dosage
- Keywords
- Infectious diarrhoea, rifamycin SV, rifamycin SV MMX, MMX
- Medical subject headings
- Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mg Rifamycin SV dosageDrug
800 mg Rifamycin SV dosageDrug
1200 mg Rifamycin SV dosageDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: 1200 mg Rifamycin SV dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 7 days
Secondary outcomes (5)
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
Measured: 48 hours
The Number of Unformed Stools Passed Per 24-h Interval
The number of unformed stools passed per 24-h interval, after dosing
Measured: 192 hours
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.
Measured: 48 hours
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.
Measured: 120 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infectious DiarrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmo Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuel Mancera Reyes, Principal investigator, HOSPITAL CENTRAL DE ORIENTECan Polat Eyigün, Principal investigator, Gülhane Military Medical Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447821
- Sponsor's protocol ID
- CB-01-11/03
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2018
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None. IPD not to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea. A Pilot, Dose Finding, Double-blind, Randomized, Multicentre Study
- ClinicalTrials.gov ID
- NCT03447821
- Acronym / sponsor ID
- CB-01-11/03
- Conditions
- Infectious Diarrhoea
- Keywords
- Infectious diarrhoea, rifamycin SV, rifamycin SV MMX, MMX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cosmo Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2008 (actual)
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Posted 9 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 400 mg Rifamycin SV dosage | Active comparator | Drug: 400 mg Rifamycin SV dosageTwo 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. |
| 800 mg Rifamycin SV dosage | Active comparator | Drug: 800 mg Rifamycin SV dosageTwo 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. |
| 1200 mg Rifamycin SV dosage | Active comparator | Drug: 1200 mg Rifamycin SV dosageTwo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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)
5 secondary outcomes
The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval
Time frame: 48 hours
The Number of Unformed Stools Passed Per 24-h Interval
Time frame: 192 hours
The Number of Patients Who Are Declared to be "Well"
Time frame: 48 hours
Number of Participants With Treatment Failure
Time frame: 120 hours
The Number of Patients Recovered From Diarrhoea
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. None. IPD not to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Mancera Reyes principal investigator
HOSPITAL CENTRAL DE ORIENTE
Can Polat Eyigün principal investigator
Gülhane Military Medical Academy
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage and 1200 mg Rifamycin SV dosage in people with Infectious Diarrhoea, run by Cosmo Technologies Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Last Unformed Stool (TLUS) (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.