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Cipro

Phase 3

Urinary Tract Infection | Small molecule | Infectious Disease |Bayer AG|Last Updated: Jun 30, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment212

FDA Designations

No designations recorded

Clinical trial landscape

Cipro · 1 trial · 1 indication

Phase 3 1
NCT00668122Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract InfectionsUrinary Tract Infection
COMPLETED212 Analytics
PHASE3COMPLETED
Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
Urinary Tract Infection
NCT00668122212
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Study Endpoints

Primary Endpoints

Bacteriological response 5 to 9 days after the last dose of study medication (TOC visit).
5-9 days

Secondary Endpoints

Bacteriological outcome during treatment
7-14 days
Bacteriological outcome at follow-up
28-42 days
Clinical outcome during treatment
7-14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
Cipro XR (Ciprofloxacin, BAYQ3939)DRUGCiprofloxacin XR 1000 mg orally once a day
Cipro IR (Ciprofloxacin, BAYQ3939)DRUGCiprofloxacin IR 500 mg orally twice a day
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main inclusion criteria: * One or more clinical symptoms and signs of a lower UTI: fever (\> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation. ...

Countries:Italy
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Competitive Landscape -Urinary Tract Infections 5 trials (matched to "Urinary Tract Infection")

CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK2PHASE1Gepotidacin
CorMedix Inc.CRMD1PHASE2Meropenem-Vaborbactam, Antibiotics
Pfizer Inc.PFE1 - Undisclosed
QIAGEN NVQGEN1 - Undisclosed
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Frequently asked questions about Cipro

What is Cipro used for?

Cipro is a small molecule antibiotic used for the treatment of complicated urinary tract infections. It is being developed by Bayer AG for this infectious disease indication and is currently in Phase 3 clinical development.

What does Cipro target?

Cipro is an antibiotic that works against bacterial infections. It is being studied for its efficacy in treating complicated urinary tract infections, a bacterial infection of the urinary system.

Who makes Cipro?

Cipro is developed by Bayer AG, a pharmaceutical company. Bayer AG is conducting clinical trials to evaluate the safety and efficacy of Cipro for the treatment of complicated urinary tract infections.

What phase is Cipro in?

Cipro is in Phase 3 clinical development. It is an investigational drug being studied for the treatment of complicated urinary tract infections and has not yet been approved for this use.

What clinical trials is Cipro in?

Cipro has been studied in a Phase 3 clinical trial (NCT00668122) that evaluated the efficacy and safety of Cipro XR versus Cipro IR in patients with complicated urinary tract infections. The trial was completed and enrolled 212 participants.

Is Cipro the same as Cipro XR?

Cipro XR is an extended-release formulation of Cipro. In a clinical trial, Cipro XR was compared to Cipro IR (immediate release) to assess their efficacy and safety in patients with complicated urinary tract infections.