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Cipro

Phase 3FDA approved

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

Cipro development status

FDA approval on record Apr 3, 1998
Approval holderBayer Hlthcare
ApplicationNDA019537
Highest phase Phase 3

Label indication CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections ( 1.1 ) • Bone and Joint Infections ( 1.2 ) • Complicated Intra-Abdominal Infections ( 1.3 ) • Infectious Diarrhea ( 1.4 ) • Typhoid Fever (Enteric Fever) ( 1.5 ) •…

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

Cipro clinical trials

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 InfectionUnlock trial analytics

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 7 trials (matched to "Urinary Tract Infection")

Top 2 of 4 competitors

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Frequently asked questions about Cipro

What is Cipro used for?

Cipro is used for urinary tract infections. It is a small molecule anti-infective developed by Bayer AG. A Phase 3 trial evaluated its use in patients with complicated urinary tract infections, comparing CIPRO XR with CIPRO IR. Cipro is also known as Cipro XR, ciprofloxacin, or BAYQ3939.

Who makes Cipro?

Cipro is made by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer developed and studied the drug, including a Phase 3 trial in complicated urinary tract infections. Cipro is also known by the names Cipro XR, ciprofloxacin, and BAYQ3939.

What phase is Cipro in?

Cipro has been studied in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The completed trial enrolled 212 patients with complicated urinary tract infections and compared CIPRO XR with CIPRO IR.

What clinical trials is Cipro in?

Cipro has been studied in one completed Phase 3 trial, NCT00668122, titled "Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections." The trial enrolled 212 patients in Italy, was randomized, double-blind, and controlled, and included adults 18 years and older.

Is Cipro the same as Cipro XR?

Yes, Cipro XR is an alternative name for Cipro. The drug is also known as ciprofloxacin or BAYQ3939. Cipro XR was compared with CIPRO IR in a Phase 3 trial for complicated urinary tract infections. All these names refer to the same active ingredient, ciprofloxacin.