A Phase 3 interventional study of Placebo and Rifamycin SV MMX in Traveler's Diarrhea, sponsored by Cosmo Technologies Ltd. Completed at 12 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-08.
Sponsored by Cosmo Technologies Ltd · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether Rifamycin SV MMX is a safe and effective treatment for Traveler's Diarrhea.
This is a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study conducted in patients traveling to developing regions with a known high incidence of TD. Eligibility will be based on a symptom complex that is highly indicative of enteric acute bacterial infection without indication of systemic infection.
Approximately 262 patients will be enrolled in the study and randomized at a 3:1 ratio to receive Rifamycin SV MMX® 400 mg or placebo orally twice daily for 3 days (72 hours). Treatment will be initiated on the day of Screening (Visit 1, Day 1), within 72 hours of onset of diarrhea. Daily doses of study drug will be taken at breakfast time and dinner time with a glass of liquid.
Safety and efficacy will be assessed.
Blood samples for routine safety tests (chemistry and hematology) will be collected at Visit 1 and at Visit 3 and sent to a local laboratory for analysis and reporting to the Investigator for safety monitoring. Urine samples for routine urinalysis (dipstick only) will be collected at Visits 1 and 3, and the results will be used by the Investigator for safety monitoring.
If a patient's diarrhea and/or signs or symptoms of enteric infection worsen in a 24 hour interval of time during the treatment period or if the enteric illness fails to improve after 24 hours or more of therapy, the patient may receive Rescue Therapy. Rescue Therapy will be prescribed by the Investigator using local standard empiric therapy and/or guided by pathogen identification.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 264 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea 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 were enrolled in the study only if they met all of the following criteria:
Exclusion Criteria
Patients were excluded from the study if they met any of the following criteria:
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Placebo (two matching tablets) orally twice daily for 3 days (72 hours)
Drug: Placebo
Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).
Drug: Rifamycin SV MMX
Placebo (two matching tablets) orally twice daily for 3 days (72 hours).
Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).
Time to Last Unformed Stool (TLUS)
The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner: Step 1: Identify when the patient achieves Clinical Cure. Step 2: Moving backwards from this time, identify the time of the last unformed stool. Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2.
Time frame: 24 hours
Clinical Cure
Clinical Cure is defined as either of the following: * Passage of two or fewer soft stools and no watery stools, no fever (\>100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24 hour interval in the 120-hr data collection period after the first dose of study drug * Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hr data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection
Time frame: 24 hours
| Milestone | Placebo | Rifamycin SV MMX |
|---|---|---|
| Started | 65 | 199 |
| Completed | 53 | 178 |
| Not completed | 12 | 21 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Use of prohibited medications | 0 | 1 |
| Withdrew: Noncompliance with study procedures | 2 | 1 |
| Withdrew: Patient required rescue medication | 8 | 17 |
The primary endpoint is TLUS defined as the interval in hours between the first dose of study drug and the last unformed stool passed just before the start of Clinical Cure. An unformed stool is defined as either a soft or watery stool. TLUS will be calculated for each patient in the following manner: Step 1: Identify when the patient achieves Clinical Cure. Step 2: Moving backwards from this time, identify the time of the last unformed stool. Step 3: The TLUS equals the time from the first dose of study drug to the time of the last unformed stool identified in Step 2.
| TLUS (hours) | Placebo | Rifamycin SV MMX |
|---|---|---|
| 25th percentile | 37.4 (8.3 to 47.8) | 21. (12.7 to 25.8) |
| 50th percentile | 68 (48.7 to NA) | 46 (42.8 to 50.5) |
| 75th percentile | NA (NA to NA) | 72.2 (69 to 91.7) |
Clinical Cure is defined as either of the following: * Passage of two or fewer soft stools and no watery stools, no fever (\>100.4 ºF or 38 ºC), and no signs or symptoms of enteric infection (other than mild excess gas/flatulence) during a 24 hour interval in the 120-hr data collection period after the first dose of study drug * Passage of no stools or only formed stools and no fever during a 48-hour interval in the 120-hr data collection period after the first dose of study drug, with or without other signs or symptoms of enteric infection
| Participants | Placebo | Rifamycin SV MMX |
|---|---|---|
| Clinical Cure | 35 | 162 |
Collected over The Investigator must completely and promptly record each new AE/SAE that occurs after the first dose of study drug through Visit 4 (i.e., treatment emergent AEs) on the appropriate CRF, even if the relationship of an AE to study drug is assessed by the Investigator to be "unlikely" or "not related". In addition, the investigator must document and follow SAEs that occur from Visit 4 through 30 days after the last dose of study drug.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/65 (0%) | 1/65 (1.5%) | 25/65 (38.5%) |
| Rifamycin SV MMX | 0/199 (0%) | 2/199 (1%) | 58/199 (29.1%) |
| Event | Placebo | Rifamycin SV MMX |
|---|---|---|
| Clostridium difficile colitisInfections and infestations | 1/65 | 0/199 |
| NeuroblastomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/65 | 1/199 |
| Abdominal pain/vomitingGastrointestinal disorders | 0/65 | 1/199 |
| Event | Placebo | Rifamycin SV MMX |
|---|---|---|
| HeadacheNervous system disorders | 6/65 | 17/199 |
| DiarrhoeaGastrointestinal disorders | 6/65 | 10/199 |
| Diarrhoea infectiousInfections and infestations | 5/65 | 10/199 |
| ConstipationGastrointestinal disorders | 1/65 | 7/199 |
| Amoebic dysenteryInfections and infestations | 2/65 | 0/199 |
| Gastrointestinal infectionInfections and infestations | 2/65 | 0/199 |
| NeutropeniaBlood and lymphatic system disorders | 1/65 | 0/199 |
| DizzinessNervous system disorders | 1/65 | 1/199 |
| AstheniaGeneral disorders | 1/65 | 0/199 |
| Clostridium difficile colitisInfections and infestations | 1/65 | 0/199 |
Intent to Treat (ITT)
| Age, Continuous(years) | Placebo | Rifamycin SV MMX | Total |
|---|---|---|---|
| Mean | 28.9 ± 12.72 | 28 ± 11.43 | 28.3 ± 11.74 |
| Sex: Female, Male(Participants) | Placebo | Rifamycin SV MMX | Total |
|---|---|---|---|
| Female | 33 | 100 | 133 |
| Male | 32 | 99 | 131 |
| Race (NIH/OMB)(Participants) | Placebo | Rifamycin SV MMX | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 9 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 10 | 15 |
| White | 56 | 175 | 231 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 5 | 8 |
| Baseline Pathogen Identified(Participants) | Placebo | Rifamycin SV MMX | Total |
|---|---|---|---|
| Yes | 48 | 133 | 181 |
| No | 17 | 66 | 83 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Cosmo Technologies Ltd