DiarrheaPhase 3NCT00328380
Prevention of Travelers' Diarrhea in Subjects Traveling Outside the U.S.
A Phase 3 study testing Rifaximin in people with Diarrhea, run by Bausch Health Americas, Inc. at 3 sites in United States.
Trial summary
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Rifaximin
- How many people
- 660 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2005to Sep 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is in good health (as determined by medical history)
- Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
- Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only)
Who cannot join
- Subject has hypersensitivity or allergy to rifaximin or rifampin
- Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
- Subject participated in an investigational drug or device study within the 30 days prior to enrollment
- Subject received rifaximin in a previous clinical study
- Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
- Subject received antidiarrheal medication (eg, loperamide, lactobacillus, BSS, Kaopectate®) within 24 hours of the first dose of study drug
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Southwest Doctors, PA
Houston, Texas, 77004
La Porte Family Clinic
La Porte, Texas, 77571
Sunshine Medical Center
South Miami, Florida, 33143
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety of Rifaximin for the Prevention of Travelers' Diarrhea in Subjects Traveling Outside the United States
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.
Read the detailed description
Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.
- Conditions
- Diarrhea
- Being tested
- Rifaximin
- Keywords
- Travelers' Diarrhea, Xifaxan, Rifaximin, Escherichia coli, E coli, EAEC, Enteroaggregative E coli, ETEC, Enterotoxigenic E coli
- Medical subject headings
- Diarrhea, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.
Secondary outcomes (1)
A secondary endpoints of this study include assessment of the differences between the 2 treatment groups based upon the proportion of subjects with TD during the 14-day Treatment Period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startDec 2005
- Primary completionDec 2006
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328380
- Sponsor's protocol ID
- RFID3004
- Status last verified
- Nov 2019
- First submitted
- 17 May 2006
- Last updated
- 25 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety of Rifaximin for the Prevention of Travelers' Diarrhea in Subjects Traveling Outside the United States
- ClinicalTrials.gov ID
- NCT00328380
- Acronym / sponsor ID
- RFID3004
- Conditions
- Diarrhea
- Keywords
- Travelers' Diarrhea, Xifaxan, Rifaximin, Escherichia coli, E coli, EAEC, Enteroaggregative E coli, ETEC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the safety and tolerability of rifaximin 600 mg (3 x 200-mg tablets) once daily compared with placebo when taken for 14 days by healthy subjects to prevent travelers' diarrhea (TD) from all causes.
Detailed description
Travelers' diarrhea (TD) is the most common illness in travelers to the developing world, occurring in 60% or more of international travelers to high-risk areas. It can be quite debilitating for the usual 2 to 4 days of the illness and may lead to disruption of travel plans. Findings from recent studies have indicated that the chronic post-travel illness may prove to be of greater clinical and public health significance than the acute illness. Specifically, persistent diarrhea has been reported in 2% to 10% of travelers developing diarrhea. Moreover, bacterial enterocolitis, including that associated with TD, leads to post-infectious irritable bowel syndrome in 4% to 31% of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is in good health (as determined by medical history)
- Subject is planning on traveling anywhere outside the US (except Canada) for at least 5 and no more than 14 days
- Subject is scheduled to depart on their planned trip no later than 14 days and no earlier than 4 days after having blood drawn for clinical laboratory assessments and urine collected for a pregnancy test (females of childbearing potential only)
Key exclusion criteria (6 listed)
- Subject has hypersensitivity or allergy to rifaximin or rifampin
- Subject has known or suspected alcohol abuse or illicit drug use within 1 year of enrollment
- Subject participated in an investigational drug or device study within the 30 days prior to enrollment
- Subject received rifaximin in a previous clinical study
- Subject received any systemic or gastrointestinal-specific antibiotic within 7 days of the first dose of study drug
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 |
|---|---|---|
| Rifaximin | Drug | – |
Primary outcome
The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.
1 secondary outcome
A secondary endpoints of this study include assessment of the differences between the 2 treatment groups based upon the proportion of subjects with TD during the 14-day Treatment Period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifaximin in people with Diarrhea, run by Bausch Health Americas, Inc. at 3 sites in United States.
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 3 inclusion and 6 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint in this study is the assessment of safety and tolerability of rifaximin 600 mg QD compared to placebo.. 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 25 Nov 2019.