Travelers' DiarrheaPhase 3NCT02920242
A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.
A Phase 3 study testing Rifaximin (Sandoz GmbH) tablet and Rifaximin (Xifaxan) in people with Travelers' Diarrhea, run by Sandoz at 1 site in Mexico.
Trial summary
This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Travelers' Diarrhea
- What is being tested?
- Rifaximin (Sandoz GmbH) tablet and Rifaximin (Xifaxan)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 15 Dec 2016to 23 May 2017
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
- International travelers with a duration of stay in host country long enough to attend schedules visits.
- Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization
Who cannot join
- Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
- Pregnant, breast feeding or planning pregnancy
- Acute diarrhea for > 72 hours immediately prior to randomization.
- Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center, Therapeutic Equivalence Study to Compare Rifaximin 200 mg Tablets (Sandoz GmbH) to Xifaxan® 200 mg Tablets (Salix Pharmaceuticals, Inc.) and Placebo in Patients With Travelers' Diarrhea
This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet.
It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study.
The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.
- Conditions
- Travelers' Diarrhea
- Being tested
- Rifaximin (Sandoz GmbH) tablet, Rifaximin (Xifaxan), Placebo
- Keywords
- Travelers, diarrhea, rifaximin, equivalence
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin (Sandoz GmbH) tabletDrug
200 mg tablet administered orally.
Rifaximin (Xifaxan)Drug
Also called Xifaxan®
200 mg tablet administered orally
PlaceboDrug
Matching Placebo tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Rifaximin | Experimental | Patients received Rifaximin 200 mg tablet 3 times per day for 3 days. Receives: Drug: Rifaximin (Sandoz GmbH) tablet |
| Xifaxan | Active comparator | Patients received Xifaxan 200 mg tablet 3 times per day for 3 days. Receives: Drug: Rifaximin (Xifaxan) |
| Placebo | Placebo comparator | Patients received placebo tablet 3 times per day for 3 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate
Clinical cure was defined as either no stools or only formed stools within a 48 hour period and no fever, with or without other enteric symptoms, OR no watery stools or no more than two soft stools passed within a 24 hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence.
Measured: study day 5 +/- 1 day
Secondary outcomes (6)
Time to Last Unformed Stool
Measured: within 5 study days
Proportion of Patients With Clinical Failure
Measured: within 5 study days
Proportion of Patients With Improvement of Diarrheal Syndrome
Measured: within 5 study days
Number of Unformed Stools
Measured: within 5 study days
The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection
Measured: within 5 study days
Microbiological Cure Rate
Measured: study day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start15 Dec 2016
- Primary completion23 May 2017
- Study completion23 May 2017
Why it stopped: Terminated due to low enrollment
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 Travelers' DiarrheaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920242
- Sponsor's protocol ID
- 1526 RIF_2
- Status last verified
- Dec 2018
- First submitted
- 29 Sep 2016
- Last updated
- 25 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center, Therapeutic Equivalence Study to Compare Rifaximin 200 mg Tablets (Sandoz GmbH) to Xifaxan® 200 mg Tablets (Salix Pharmaceuticals, Inc.) and Placebo in Patients With Travelers' Diarrhea
- ClinicalTrials.gov ID
- NCT02920242
- Acronym / sponsor ID
- 1526 RIF_2
- Conditions
- Travelers' Diarrhea
- Keywords
- Travelers, diarrhea, rifaximin, equivalence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low enrollment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Posted 25 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet.
It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study.
The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rifaximin | Experimental | Drug: Rifaximin (Sandoz GmbH) tabletPatients received Rifaximin 200 mg tablet 3 times per day for 3 days. |
| Xifaxan | Active comparator | Drug: Rifaximin (Xifaxan)Patients received Xifaxan 200 mg tablet 3 times per day for 3 days. |
| Placebo | Placebo comparator | Drug: PlaceboPatients received placebo tablet 3 times per day for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
- International travelers with a duration of stay in host country long enough to attend schedules visits.
- Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization
Key exclusion criteria (4 listed)
- Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
- Pregnant, breast feeding or planning pregnancy
- Acute diarrhea for > 72 hours immediately prior to randomization.
- Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.
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 (Sandoz GmbH) tablet200 mg tablet administered orally. | Drug | Rifaximin |
| Rifaximin (Xifaxan)Also: Xifaxan®200 mg tablet administered orally | Drug | Xifaxan |
| PlaceboMatching Placebo tablet administered orally | Drug | Placebo |
Primary outcome
Clinical Cure Rate
Time frame: study day 5 +/- 1 day
Clinical cure was defined as either no stools or only formed stools within a 48 hour period and no fever, with or without other enteric symptoms, OR no watery stools or no more than two soft stools passed within a 24 hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence.
6 secondary outcomes
Time to Last Unformed Stool
Time frame: within 5 study days
Proportion of Patients With Clinical Failure
Time frame: within 5 study days
Proportion of Patients With Improvement of Diarrheal Syndrome
Time frame: within 5 study days
Number of Unformed Stools
Time frame: within 5 study days
The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection
Time frame: within 5 study days
Microbiological Cure Rate
Time frame: study day 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 (Sandoz GmbH) tablet and Rifaximin (Xifaxan) in people with Travelers' Diarrhea, run by Sandoz at 1 site in Mexico.
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 4 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: stopped early, as of the sponsor's last update on 25 Mar 2019. 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 Mexico. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2019). 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?
Clinical Cure Rate (time frame: study day 5 +/- 1 day). 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 Mar 2019.