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levofloxacin

Phase 4FDA approved

Bronchitis | Small molecule | Respiratory |Johnson & Johnson|Trials Updated: Sep 13, 2013

levofloxacin development status

FDA approval on record Oct 21, 2004
Approval holderJanssen Pharms
ApplicationNDA021721
Highest phase Phase 4 run by Dr. Reddy's Laboratories Limited (NCT03160807)
Phase scored for JNJPhase 3
Registered trials 54 across 23 sponsors since Aug 2001

levofloxacin target and mechanism

ModalitySmall molecule

Also known as levofloxacin oral solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials19
Total Enrollment9,137

FDA Designations

No designations recorded

levofloxacin clinical trials

levofloxacin · 19 trials · 18 indications

Phase 3 15Phase 2 3Phase 1 1
NCT00402688An Effectiveness and Safety Study for Levofloxacin in Chronic ProstatitisProstatitis
COMPLETED242 Analytics
NCT00210886A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.Urinary Tract Infections
COMPLETED1,109 Analytics
NCT00236652A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.Maxillary Sinusitis
COMPLETED18 Analytics
NCT00044473A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to TreatOtitis Media
COMPLETED206 Analytics
NCT00236522A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.Sinusitis
COMPLETED784 Analytics
NCT00034736A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient SettingPneumonia
COMPLETED691 Analytics
NCT00042718A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis.Bronchitis
COMPLETED659 Analytics
NCT00236821A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With PneumoniaPneumonia
COMPLETED530 Analytics
NCT00236808A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial ProstatitisProstatitis
COMPLETED383 Analytics
NCT00249197A Study of the Safety and Effectiveness of Levofloxacin Compared to Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Skin InfectionsSkin Diseases, Bacterial
COMPLETED413 Analytics
PHASE3COMPLETED
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
Prostatitis
NCT00402688242
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PHASE3COMPLETED
A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.
Urinary Tract Infections
NCT002108861,109
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PHASE3COMPLETED
A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.
Maxillary Sinusitis
NCT0023665218
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PHASE3COMPLETED
A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat
Otitis Media
NCT00044473206
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PHASE3COMPLETED
A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.
Sinusitis
NCT00236522784
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PHASE3COMPLETED
A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting
Pneumonia
NCT00034736691
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PHASE3COMPLETED
A Study of the Effectiveness and Safety of High Dose, Short-course Levofloxacin in the Treatment of Acute Bacterial Exacerbation (Worsening) of Chronic Bronchitis.
Bronchitis
NCT00042718659
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PHASE3COMPLETED
A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia
Pneumonia
NCT00236821530
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PHASE3COMPLETED
A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis
Prostatitis
NCT00236808383
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PHASE3COMPLETED
A Study of the Safety and Effectiveness of Levofloxacin Compared to Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Skin Infections
Skin Diseases, Bacterial
NCT00249197413
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Study Endpoints

Primary Endpoints

Clinical Success
Posttherapy Visit (Study Day 33-36)

Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.

Combination of clinical success and microbiologic eradication (known as therapeutic response) at post-therapy visit.
Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.
Rate of elimination of the disease-producing bacteria identified at the start of the study; signs and symptoms and microscopic evidence of cure
Clinical success (resolution of patient signs and symptoms) at the post-therapy visit.
Clinical cure rate (cured or not cured) at 10-17 days after the last dose of study medication.
Clinical response rates based on signs and symptoms at posttherapy visit.
Microbiologic eradication of bacteria at posttherapy visit
Clinical response rates at post-therapy, categorized as cured, improved, or failed.
Clinical response rate (a reduction in signs and symptoms, and stabilization/improvement of sinus x-ray results) at post-therapy visit, 2 - 5 days after the last dose of study drug
Clinical response rate (reduction in signs and symptoms) at post-therapy (5 - 7 days after the last dose of study drug)
Clinical response, the resolution of signs and symptoms at post-therapy compared with those at the start of study; Microbiological response, the eradication at post-therapy of infectious organism identified at start of study.
Clinical response rate at post-therapy (defined as cured, improved or failed); microbiological response at post-therapy (rate of elimination of disease-causing bacteria, by patient, and by type of bacteria); incidence of adverse events
Clinical response, the resolution of signs and symptoms at post-therapy compared with those at start of study; Microbiological response, the eradication at post-therapy of infectious organism identified at start of study.
Clinical response rate (defined as cured, improved or failed) 2 - 7 days after the last dose of the study drug; rate of elimination of disease-causing bacteria (by patient, and by type of bacteria); incidence of adverse events.
Clinical response rate (reduction in signs and symptoms, improvement in x-ray findings) at post-therapy (5 - 7 days after the last dose of study drug).
Rate of elimination of disease-causing bacteria, by patient, and by type of bacteria, 5 - 7 days after the last dose of study drug.
Evaluation of the pharmacokinetics of two dosing regimens of levofloxacin in renally impaired and dialysis patients.

Secondary Endpoints

Symptom Relief (Resolved)
Posttherapy Visit (Study Day 33-36)
Clinical Success (Non-Relapse) or Failure (Relapse)
Poststudy Telephone contact at 6 weeks
Total NIH-CPSI Score
Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001ACTIVE_COMPARATORlevofloxacin 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
002ACTIVE_COMPARATORlevofloxacin 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
003ACTIVE_COMPARATORlevofloxacin 500mg tablet once daily for 4 weeks.

Interventions

NameTypeDescription
levofloxacinDRUG750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
levofloxacin, azithromycin, amoxicillin/clavulanateDRUG -
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Eligibility Criteria

Age Range40 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Males 40 years of age or older * A clinical diagnosis of chronic prostatitis as evidenced by the following two criteria: 1. Clinical signs and symptoms of prostatitis including a soft, tender prostate without noticeable nodularity with one or more of the following signs or sym...

Countries:United States
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Frequently asked questions about levofloxacin

What is levofloxacin used for?

Levofloxacin is a small molecule antibiotic studied for respiratory and related bacterial infections, including bronchitis, chronic bronchitis, maxillary sinusitis, otitis media, pneumonia, and prostatitis. It has been evaluated in Phase 3 clinical trials for these indications, with completed studies in chronic prostatitis and chronic bronchitis.

Who makes levofloxacin?

Levofloxacin is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company has sponsored clinical trials of the drug, including studies in chronic prostatitis and chronic bronchitis.

What phase is levofloxacin in?

Levofloxacin has been studied in Phase 3 clinical trials. The drug is investigational in the contexts described here, and the trials listed are completed. There are no active trials for levofloxacin in the current dataset.

What clinical trials is levofloxacin in?

Levofloxacin has been evaluated in completed clinical trials including NCT00402688 in chronic prostatitis, NCT00269932 in chronic bronchitis, and NCT00258102 in complicated urinary tract infections. A Phase 1 pharmacokinetics study, NCT00645437, was conducted in patients with varying degrees of renal function.

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