Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea
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ClinicalTrials.gov Identifier: NCT00292344 |
Recruitment Status :
Completed
First Posted : February 15, 2006
Last Update Posted : April 20, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Travelers' Diarrhea | Drug: Rifaximin and loperamide | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 316 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Rifaximin in Standard Three-Day Dosing With and Without the Antimotility Drug, Loperamide, in the Treatment of Travelers' Diarrhea |
Study Start Date : | June 2004 |
Study Completion Date : | August 2005 |
- The major outcome parameter was time from initiation of therapy until passage of the last unformed stool before becoming well (TLUS).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292344
Mexico | |
Universidad Autonoma de Guadalajara | |
Guadalajara, Jalisco, Mexico | |
University of Arizona, Colegio Guadalajara | |
Guadalajara, Jalisco, Mexico | |
University of San Diego at Iteso | |
Guadalajara, Jalisco, Mexico | |
Clinica Londres Morelos | |
Cuernavaca, Morelos, Mexico |
Principal Investigator: | Herbert L. DuPont, MD | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00292344 |
Other Study ID Numbers: |
TRA-04-01 |
First Posted: | February 15, 2006 Key Record Dates |
Last Update Posted: | April 20, 2009 |
Last Verified: | February 2006 |
Travelers' diarrhea rifaximin loperamide enterotoxigenic E. coli |
Dysentery Diarrhea Signs and Symptoms, Digestive Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Rifaximin Loperamide Antidiarrheals Anti-Bacterial Agents Anti-Infective Agents Gastrointestinal Agents |