DiarrhoeaPhase 3NCT00979056
Prophylactic Treatment of Travellers' Diarrhoea With Rifaximin
A Phase 3 study testing Rifaximin and Lactose in people with Diarrhoea, run by Dr. Philipp Zanger, MD MSc DTM at 1 site in Germany.
Trial summary
The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhoea
- What is being tested?
- Rifaximin and Lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2009to Oct 2012
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults ≥ 18 and < 65 years
- Good general condition (according to history and clinical examination)
- Written informed consent
- No pregnancy
- No breast feeding
- Efficacious contraception (e.g. oral, double-barrier) during the study and 4 weeks after termination of the study
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- No participation in other clinical trials 4 weeks before, during participation, and 4 weeks after participation in this study
- Planned travel period between 6 and 28 days
- Planned travel to South- and Southeast Asia
- Planned time to arrival in South- or Southeast Asia ≤ 24 hours
Who cannot join
- Pregnancy
- Breast feeding
- Age < 18 and ≥ 65 years
- No written informed consent
- Chronic gastrointestinal disease and/ or immune insufficiency
- Low general condition (according to history and clinical examination)
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- Regular medication with gastrointestinal side-effects and/or immunosuppressive medication
- Participation in other clinical trials 4 weeks before, during and 4 weeks after termination of the study
- No efficacious contraception
- Planned travel period < 6 and > 28 days
- Planned travel outside South- and Southeast Asia
- Vaccination against cholera using DUKORAL within 12 months prior to inclusion
- Planned time to arrival in South- or Southeast Asia > 24 hours
- Known hypersensitivity against rifaximin or rifamycin-derivatives in general
- Known lactose intolerance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Tropical Medicine, University Hospital of Tübingen
Tübingen, 72074
About this study
Official title: Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeast-Asia
The aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
- Conditions
- Diarrhoea
- Being tested
- Rifaximin, Lactose
- Keywords
- Traveller's diarrhoea, Prevention
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Xifaxan, Normix, ATC code A07AA11, Chemical Abstracts Service (CAS) 80621814
400 mg per day, oral use, maximum duration 28 days
LactoseDrug
Coated Tablet, Oral Use
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Not described Receives: Drug: Rifaximin |
| Lactose | Placebo comparator | Not described Receives: Drug: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection.
Measured: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
Secondary outcomes (2)
Documentation of adverse effects and tolerance of prophylaxis with rifaximin.
Measured: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
Evaluation of prevention of post infectious irritable bowel syndrome.
Measured: From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Philipp Zanger, MD MSc DTM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Philipp Zanger, MD MSc DTM, University Hospital Tuebingen
- Investigators
- Philipp G. Zanger, MD MSc DTM, Principal investigator, Institute of Tropical Medicine, University Hospital of Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979056
- Sponsor's protocol ID
- Rifa1
- Other IDs
- 2007-003986-42
- Status last verified
- Nov 2013
- First submitted
- 16 Sep 2009
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zanger P, Nurjadi D, Gabor J, Gaile M, Kremsner PG. Effectiveness of rifaximin in prevention of diarrhoea in individuals travelling to south and southeast Asia: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2013 Nov;13(11):946-54. doi: 10.1016/S1473-3099(13)70221-4. Epub 2013 Sep 4.
PubMed 24012319
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomised, Placebo Controlled, Double Blind Monocenter Trial for the Prophylactic Treatment of Diarrhoea With Rifaximin for Travellers to South- and Southeast-Asia
- ClinicalTrials.gov ID
- NCT00979056
- Acronym / sponsor ID
- Rifa1
- Conditions
- Diarrhoea
- Keywords
- Traveller's diarrhoea, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Dr. Philipp Zanger, MD MSc DTMUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Sep 2009 (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 aim of the study is to investigate the efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: Rifaximin |
| Lactose | Placebo comparator | Drug: Lactose |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adults ≥ 18 and < 65 years
- Good general condition (according to history and clinical examination)
- Written informed consent
- No pregnancy
- No breast feeding
Key exclusion criteria (15 listed)
- Pregnancy
- Breast feeding
- Age < 18 and ≥ 65 years
- No written informed consent
- Chronic gastrointestinal disease and/ or immune insufficiency
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 |
|---|---|---|
| RifaximinAlso: Xifaxan, Normix, ATC code A07AA11, Chemical Abstracts Service (CAS) 80621814400 mg per day, oral use, maximum duration 28 days | Drug | Rifaximin |
| LactoseCoated Tablet, Oral Use | Drug | Lactose |
Primary outcome
Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection.
Time frame: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
2 secondary outcomes
Documentation of adverse effects and tolerance of prophylaxis with rifaximin.
Time frame: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
Evaluation of prevention of post infectious irritable bowel syndrome.
Time frame: From the first day of the travel (travel period between 6 and 28 days) to 6 months after the subject's return to Germany
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 8 Nov 2013.
- Results publication: PubMed 24012319Zanger P, Nurjadi D, Gabor J, Gaile M, Kremsner PG. Effectiveness of rifaximin in prevention of diarrhoea in individuals travelling to south and southeast Asia: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2013 Nov;13(11):946-54. doi: 10.1016/S1473-3099(13)70221-4. Epub 2013 Sep 4.
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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.
Philipp G. Zanger, MD MSc DTM principal investigator
Institute of Tropical Medicine, University Hospital of Tübingen
1 site 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 and Lactose in people with Diarrhoea, run by Dr. Philipp Zanger, MD MSc DTM at 1 site in Germany.
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 10 inclusion and 15 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection. (time frame: From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00979056, which also lists 1 linked publication.
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 8 Nov 2013.