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Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
This study has been completed.
Sponsor:
Optimer Pharmaceuticals LLC
Information provided by:
Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00448422
First received: March 15, 2007
Last updated: September 22, 2010
Last verified: September 2010
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Purpose
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of patients with acute bacterial gastroenteritis (traveler's diarrhea.
| Condition | Intervention | Phase |
|---|---|---|
| Acute Bacterial Gastroenteritis | Drug: prulifloxacin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Optimer Pharmaceuticals LLC:
Primary Outcome Measures:
- Time to Last Unformed Stool (TLUS) [ Time Frame: End of Therapy ]
Secondary Outcome Measures:
- Microbiologic eradication rates [ Time Frame: End of therapy/study ]
- Clinical cure based on relief of signs and symptoms [ Time Frame: End of therapy/study ]
| Enrollment: | 268 |
| Study Start Date: | December 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Tablet
|
Drug: prulifloxacin
Tablet
|
|
Placebo Comparator: 2
Tablet
|
Drug: prulifloxacin
Tablet
|
Detailed Description:
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe other gastrointestinal-related symptoms, or tenesmus of <72 hours duration.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448422
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448422
Locations
| India | |
| Goa Medical College | |
| Bambolim, Goa, India | |
Sponsors and Collaborators
Optimer Pharmaceuticals LLC
Investigators
| Study Director: | Robert Steffen, MD | University of Zurich |
More Information
| Responsible Party: | Y.K. Shue, Optimer Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00448422 History of Changes |
| Other Study ID Numbers: |
OPT-099-002 |
| Study First Received: | March 15, 2007 |
| Last Updated: | September 22, 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 |
Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017