Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00448422 |
Recruitment Status :
Completed
First Posted : March 16, 2007
Last Update Posted : September 27, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Bacterial Gastroenteritis | Drug: prulifloxacin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 268 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Tablet
|
Drug: prulifloxacin
Tablet |
Placebo Comparator: 2
Tablet
|
Drug: prulifloxacin
Tablet |
- Time to Last Unformed Stool (TLUS) [ Time Frame: End of Therapy ]
- Microbiologic eradication rates [ Time Frame: End of therapy/study ]
- Clinical cure based on relief of signs and symptoms [ Time Frame: End of therapy/study ]

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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:
- Diagnosis of acute bacterial gastroenteritis
- Traveler from an industrialized country
- Capable of giving Informed Consent
Exclusion Criteria:
- Fever (>100.3 degrees)
- Pregnant or Breast Feeding or Not using adequate birth control
- Known or Suspected (co-)Infection with non-bacterial pathogen
- Symptoms of acute gastroenteritis of >72 hours duration
- Bloody Diarrhea
- Concomitant antibacterial with activity against enteric bacterial pathogens
- History of IBD
- Unable/Unwilling to comply with study protocol
- Greater than two doses of an antidiarrheal medication within 24 hours
- > 2 doses of anti-diarrheal medication within 24 hours
- Antimicrobial treatment within 30 days

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): NCT00448422
India | |
Goa Medical College | |
Bambolim, Goa, India |
Study Director: | Robert Steffen, MD | University of Zurich |
Responsible Party: | Y.K. Shue, Optimer Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00448422 History of Changes |
Other Study ID Numbers: |
OPT-099-002 |
First Posted: | March 16, 2007 Key Record Dates |
Last Update Posted: | September 27, 2010 |
Last Verified: | September 2010 |
Keywords provided by Optimer Pharmaceuticals LLC:
Traveler's Diarrhea |
Additional relevant MeSH terms:
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Prulifloxacin Fluoroquinolones Anti-Bacterial Agents Anti-Infective Agents |
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