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Prulifloxacin

Phase 3

Acute Gastroenteritis in Adult Travelers | Small molecule | Gastrointestinal |Merck & Company, Inc.|Last Updated: May 15, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment282

FDA Designations

No designations recorded

Clinical trial landscape

Prulifloxacin · 2 trials · 2 indications

Phase 3 2
NCT00448422Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult TravelersAcute Bacterial Gastroenteritis
COMPLETED268 Analytics
NCT00392574Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's DiarrheaAcute Gastroenteritis in Adult Travelers
COMPLETED282 Analytics
PHASE3COMPLETED
Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers
Acute Bacterial GastroenteritisUnlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Prulifloxacin Versus Placebo in Traveler's Diarrhea
Acute Gastroenteritis in Adult TravelersUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to Last Unformed Stool (TLUS)
End of Therapy
Time to last unformed stool
Study days 1-3

Secondary Endpoints

Microbiologic eradication rates
End of therapy/study
Clinical cure based on relief of signs and symptoms
End of therapy/study
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTablet
2PLACEBO_COMPARATORTablet

Interventions

NameTypeDescription
prulifloxacinDRUGTablet
PlaceboDRUGTablet
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:IndiaUnited States
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Frequently asked questions about Prulifloxacin

What is Prulifloxacin used for?

Prulifloxacin is an investigational small molecule being studied for the treatment of acute gastroenteritis in adult travelers and acute bacterial gastroenteritis. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development.

What does Prulifloxacin target?

Prulifloxacin is a fluoroquinolone antibiotic that works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication. This action leads to the death of susceptible bacteria, making it effective against gastrointestinal pathogens causing acute gastroenteritis.

Who makes Prulifloxacin?

Prulifloxacin is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 3 clinical trials for acute gastroenteritis in adult travelers.

What phase is Prulifloxacin in?

Prulifloxacin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed to evaluate its safety and efficacy in treating acute gastroenteritis in adult travelers.

What clinical trials is Prulifloxacin in?

Prulifloxacin has been studied in two completed Phase 3 clinical trials. NCT00392574 enrolled 282 participants in the United States, and NCT00448422 enrolled 268 participants in India. Both trials were randomized, double-blind, placebo-controlled studies evaluating the drug for acute gastroenteritis in adult travelers.

Is Prulifloxacin the same as other fluoroquinolones?

Prulifloxacin is a fluoroquinolone antibiotic, a class that includes drugs like ciprofloxacin and levofloxacin. However, Prulifloxacin is a distinct compound with its own chemical structure and is being developed specifically for acute gastroenteritis in adult travelers.