A Phase 2 interventional study of 400 mg Rifamycin SV dosage and 800 mg Rifamycin SV dosage in Infectious Diarrhoea, sponsored by Cosmo Technologies Ltd. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-18.
Sponsored by Cosmo Technologies Ltd · Phase 2, Interventional, and Treatment
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.
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:
Secondary end-points to determine:
44 studies on the registry are indexed under Dysentery; 6 are open to participants now.
This study's enrollment of 40 is below the median of 163 across 38 interventional studies indexed under Dysentery.
Browse Dysentery studies →Cosmo Technologies Ltd is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients had to meet all of the following inclusion criteria:
Exclusion Criteria:
Patients had not to have had of any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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)
Time frame: Up to 7 days
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
Time frame: 48 hours
The Number of Unformed Stools Passed Per 24-h Interval
The number of unformed stools passed per 24-h interval, after dosing
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours
| Milestone | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage |
|---|---|---|---|
| Started | 14 | 13 | 13 |
| Completed | 13 | 12 | 12 |
| Not completed | 1 | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
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)
| hours | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage |
|---|---|---|---|
| Time to Last Unformed Stool (TLUS) | 59.3 ± 12.1 | 51.4 ± 12.3 | 57.4 ± 13.1 |
The evaluation of improvement in diarrhoea during a 48 hour interval is defined as a \>50% reduction of bowel movements versus the baseline value
| Participants | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage |
|---|---|---|---|
| Showed improvement within 48 hrs | 4 | 9 | 6 |
| Showed no improvement within 48 hrs | 9 | 3 | 6 |
The number of unformed stools passed per 24-h interval, after dosing
| Unformed stools | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage |
|---|---|---|---|
| 0-24 h | 5.23 ± 2.74 | 4.67 ± 3.17 | 4.73 ± 3.41 |
| 24-48 h | 2.15 ± 1.95 | 1.5 ± 1.57 | 2.64 ± 2.66 |
| 48-72 h | 2.09 ± 1.64 | 1.29 ± 1.6 | 1.7 ± 1.95 |
| 72-96 h | 1.5 ± 1.29 | 1.67 ± 2.08 | 1.8 ± 2.05 |
| 96-120 h | 1.5 ± 0.71 | 1.5 ± 2.12 | 0.75 ± 0.96 |
| 120-144 h | 3 ± 0 | 0.5 ± 0.71 | 1 ± 0 |
| 144-168 h | 3 ± 0 | 1 ± 0 | 1 ± 0 |
| 168-192 h | 0 ± 0 | 1 ± 0 | 1 ± 0 |
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.
| Participants | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage |
|---|---|---|---|
| Wellness Yes | 13 | 10 | 2 |
| Wellness No | 0 | 2 | 9 |
A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose.
| Participants | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage |
|---|---|---|---|
| No | 12 | 10 | 9 |
| Yes | 1 | 2 | 2 |
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.
| Participants | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage |
|---|---|---|---|
| No | 1 | 2 | 2 |
| Yes | 12 | 10 | 9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 400 mg Rifamycin SV Dosage | 0/13 (0%) | 0/13 (0%) | 4/13 (30.8%) |
| 800 mg Rifamycin SV Dosage | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| 1200 mg Rifamycin SV Dosage | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Event | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage |
|---|---|---|---|
| GASTROINTESTINAL DISORDERSGastrointestinal disorders | 2/13 | 3/12 | 1/12 |
| NERVOUS SYSTEMNervous system disorders | 0/13 | 0/12 | 3/12 |
| GENERAL DISORDERSGeneral disorders | 2/13 | 0/12 | 0/12 |
| CARDIAC DISORDERSCardiac disorders | 0/13 | 0/12 | 1/12 |
| MUSCULOSKELETALMusculoskeletal and connective tissue disorders | 0/13 | 0/12 | 1/12 |
| PSYCHIATRIC DISORDERSPsychiatric disorders | 1/13 | 0/12 | 0/12 |
| SKIN AND SUBCUTANEOUSSkin and subcutaneous tissue disorders | 1/13 | 0/12 | 0/12 |
Intent To Treat
| Age, Continuous(years) | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage | Total |
|---|---|---|---|---|
| Mean | 39.5 ± 12.1 | 37.3 ± 15.9 | 41.9 ± 12.7 | 39.6 ± 13.4 |
| Sex: Female, Male(Participants) | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage | Total |
|---|---|---|---|---|
| Female | 6 | 8 | 7 | 21 |
| Male | 7 | 4 | 5 | 16 |
| Height (cm)(cm) | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage | Total |
|---|---|---|---|---|
| Mean | 165.2 ± 9.8 | 160.8 ± 9.7 | 159.1 ± 6.2 | 161.8 ± 8.9 |
| Weight (kg)(kg) | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage | Total |
|---|---|---|---|---|
| Mean | 72.3 ± 16.7 | 72.9 ± 17 | 70.3 ± 11.8 | 71.8 ± 15 |
| Axillary Temperature (°C)(Degrees Celsius) | 400 mg Rifamycin SV Dosage | 800 mg Rifamycin SV Dosage | 1200 mg Rifamycin SV Dosage | Total |
|---|---|---|---|---|
| Mean | 36.8 ± 0.5 | 36.8 ± 0.4 | 36.7 ± 0.4 | 36.8 ± 0.4 |
No study locations are listed for this record.
Plan to share: No — None. IPD not to be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Cosmo Technologies Ltd