Travelers' DiarrheaPhase 4NCT00292344
Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea
A Phase 4 study testing Rifaximin and loperamide in people with Travelers' Diarrhea, run by The University of Texas Health Science Center, Houston at 4 sites in Mexico.
Trial summary
Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment. 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 and loperamide
- How many people
- 316 participants
- Where
- 4 sitesMexico
- Study dates
- Jun 2004to Aug 2005
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria include: IRB approval; signing of a consent form;18 years of age or older, providing of an unformed pre-treatment stool; females must be non-pregnant and not nursing.
Who cannot join
- Exclusion criteria include: diarrhea longer than 72 hours; moderate or severe dehydration, pregnancy or breast feeding, receipt of trimethoprim-sulfamethoxazole, azalide, doxycycline, or a fluoroquinolone in the past week; unstable medical condition; hypersensitivity to rifaximin or rifampin; fever (>100.6o F) or bloody diarrhea.
Trial locations and contacts
4 sites in 1 country.
Mexico4 sites
Clinica Londres Morelos
Cuernavaca, Morelos
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco
University of Arizona, Colegio Guadalajara
Guadalajara, Jalisco
University of San Diego at Iteso
Guadalajara, Jalisco
About this study
Official title: Rifaximin in Standard Three-Day Dosing With and Without the Antimotility Drug, Loperamide, in the Treatment of Travelers' Diarrhea
Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
Read the detailed description
During short-term study, adult U.S. students in Mexico (n = 310) with acute diarrhea (≥ 3 unformed stools with enteric symptoms) were enrolled in a double-blind, randomized trial wherein they were given rifaximin 200 mg three times a day for 3 days (R) (n = 102), loperamide 4 mg initially followed by 2 mg after each unformed stool not to exceed 8 mg/day for 2 days (L) (n = 104) or both drugs in the same dosage schedule (L/R) (n = 104). The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).
- Conditions
- Travelers' Diarrhea
- Being tested
- Rifaximin and loperamide
- Keywords
- Travelers' diarrhea, rifaximin, loperamide, enterotoxigenic E. coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin and loperamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).
Secondary outcomes (16)
Secondary Outcome Variables:
1. Time to passage of last unformed stool - standard definition of TLUS for antibiotics (18, 20) where wellness is declared at any time during 5 days regardless of later recurrence of continuing illness during the observation period;
2. Number of unformed stools passed during two days of therapy;
3. Number of unformed stools passed during the five days of study;
4. Improvement in diarrhea (<half the number of daily entry unformed stools in 24 hours) by 24 hours and 48 hours;
5. Treatment failure defined as: a. failure to achieve wellness during five days of study (achieve a TLUS-5 d); b. Deterioration during treatment and removed from further clinical evaluation, or, c. Occurrence of a relapse after achieving wellness during
6. Occurrence of relapse during five day surveillance (occurrence of diarrhea after having a TLUS);
7. TLUS in 48 hours - last unformed stool passed during the 48 hours that loperamide is being given (rapid symptomatic improvement);
8. Number of days of moderate or severe enteric symptoms;
9. Number of days passing any number of unformed stools plus any degree (mild, moderate or severe) of daily enteric symptoms (must have both present each day);
10. Subjects global assessment of efficacy by day of study;
11. Number of hours where schedule of activities were altered because of illness;
12. Number of hours confined to bed because of diarrhea;
13. Dropped from study due to adverse reaction;
14. Number of doses of loperamide (or loperamide placebos) taken;
15. Microbiologic eradication/failure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJun 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Travelers' DiarrheaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 316 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Investigators
- Herbert L. DuPont, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292344
- Sponsor's protocol ID
- TRA-04-01
- Status last verified
- Feb 2006
- First submitted
- 13 Feb 2006
- Last updated
- 20 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin in Standard Three-Day Dosing With and Without the Antimotility Drug, Loperamide, in the Treatment of Travelers' Diarrhea
- ClinicalTrials.gov ID
- NCT00292344
- Acronym / sponsor ID
- TRA-04-01
- Conditions
- Travelers' Diarrhea
- Keywords
- Travelers' diarrhea, rifaximin, loperamide, enterotoxigenic E. coli
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Jun 2004
- Study completion
- Aug 2005
- First posted
- 15 Feb 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.
Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
Detailed description
During short-term study, adult U.S. students in Mexico (n = 310) with acute diarrhea (≥ 3 unformed stools with enteric symptoms) were enrolled in a double-blind, randomized trial wherein they were given rifaximin 200 mg three times a day for 3 days (R) (n = 102), loperamide 4 mg initially followed by 2 mg after each unformed stool not to exceed 8 mg/day for 2 days (L) (n = 104) or both drugs in the same dosage schedule (L/R) (n = 104). The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria include: IRB approval; signing of a consent form;18 years of age or older, providing of an unformed pre-treatment stool; females must be non-pregnant and not nursing.
Key exclusion criteria (1 listed)
- Exclusion criteria include: diarrhea longer than 72 hours; moderate or severe dehydration, pregnancy or breast feeding, receipt of trimethoprim-sulfamethoxazole, azalide, doxycycline, or a fluoroquinolone in the past week; unstable medical condition; hypersensitivity to rifaximin or rifampin; fever (>100.6o F) or bloody diarrhea.
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 and loperamide | Drug | – |
Primary outcome
The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).
16 secondary outcomes
Secondary Outcome Variables:
1. Time to passage of last unformed stool - standard definition of TLUS for antibiotics (18, 20) where wellness is declared at any time during 5 days regardless of later recurrence of continuing illness during the observation period;
2. Number of unformed stools passed during two days of therapy;
3. Number of unformed stools passed during the five days of study;
4. Improvement in diarrhea (<half the number of daily entry unformed stools in 24 hours) by 24 hours and 48 hours;
5. Treatment failure defined as: a. failure to achieve wellness during five days of study (achieve a TLUS-5 d); b. Deterioration during treatment and removed from further clinical evaluation, or, c. Occurrence of a relapse after achieving wellness during
6. Occurrence of relapse during five day surveillance (occurrence of diarrhea after having a TLUS);
7. TLUS in 48 hours - last unformed stool passed during the 48 hours that loperamide is being given (rapid symptomatic improvement);
8. Number of days of moderate or severe enteric symptoms;
9. Number of days passing any number of unformed stools plus any degree (mild, moderate or severe) of daily enteric symptoms (must have both present each day);
10. Subjects global assessment of efficacy by day of study;
11. Number of hours where schedule of activities were altered because of illness;
12. Number of hours confined to bed because of diarrhea;
13. Dropped from study due to adverse reaction;
14. Number of doses of loperamide (or loperamide placebos) taken;
15. Microbiologic eradication/failure.
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 20 Apr 2009.
Related trials for Travelers' Diarrhea
RecruitingPhase 4
Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
Diarrhoea;Acute, Diarrhea Travelers
RecruitingEarly Phase 1
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Travelers Diarrhea
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.
Herbert L. DuPont, MD principal investigator
The University of Texas Health Science Center, Houston
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin and loperamide in people with Travelers' Diarrhea, run by The University of Texas Health Science Center, Houston at 4 sites 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 1 inclusion and 1 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 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).. 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 20 Apr 2009.