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Ofloxacin

Phase 3

Pelvic Inflammatory Disease | Small molecule | Infectious Disease |Bayer AG|Last Updated: Oct 15, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment749

FDA Designations

No designations recorded

Clinical trial landscape

Ofloxacin · 1 trial · 1 indication

Phase 3 1
NCT00683865Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.Pelvic Inflammatory Disease
COMPLETED749 Analytics
PHASE3COMPLETED
Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.
Pelvic Inflammatory DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical response 5 to 24 days after the last dose of study medication
5 to 24 days after the last dose

Secondary Endpoints

Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication
visit 28 to 42 days after last dose
Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose
(Day 4-7) and at follow-up 28 to 42 days after last dose
Reduction from baseline in pain report at the different assessment visits
Over the entire trial period (overall)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
OfloxacinDRUGOfloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
Avelox (Moxifloxacin, BAY12-8039)DRUGMoxifloxacin 400 mg po od for 14 days
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites77

Inclusion Criteria: * Diagnosis of PID based on: pelvic discomfort- Direct lower abdominal tenderness; * Adnexal tenderness on bimanual vaginal examination, * Temperature \> 38.0°C; - Elevated C-reactive protein value (CRP); * Signed PIC/IC Exclusion Criteria: * Pregnancy * Abnormal lab values

Countries:DenmarkFinlandFranceGermanyGreeceHungaryItalyLithuaniaPolandRussiaSouth AfricaSwedenUnited Kingdom
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Frequently asked questions about Ofloxacin

What is Ofloxacin used for in Pelvic Inflammatory Disease?

Ofloxacin is a small molecule antibiotic used for the treatment of Pelvic Inflammatory Disease (PID), a bacterial infection of the female reproductive organs. It is being developed by Bayer AG for this indication and is currently in Phase 3 clinical development.

What does Ofloxacin target?

Ofloxacin is a fluoroquinolone antibiotic that works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair. This mechanism is effective against a broad range of gram-negative and gram-positive bacteria, making it useful in treating pelvic inflammatory disease.

Who makes Ofloxacin?

Ofloxacin is developed by Bayer AG, a multinational pharmaceutical company headquartered in Germany. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate Ofloxacin for the treatment of Pelvic Inflammatory Disease.

What phase is Ofloxacin in?

Ofloxacin is in Phase 3 clinical development for the treatment of Pelvic Inflammatory Disease. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial, NCT00683865, has been completed, and the drug is not currently in active clinical trials.

What clinical trials is Ofloxacin in?

Ofloxacin has been studied in one Phase 3 clinical trial, NCT00683865, titled 'Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.' This randomized, double-blind, active-controlled trial enrolled 749 female participants aged 18 years and older across multiple countries, including Denmark, Finland, France, Germany, and the United Kingdom.

Is Ofloxacin the same as Moxifloxacin?

No, Ofloxacin and Moxifloxacin are different antibiotics. Both are fluoroquinolones, but they have distinct chemical structures and spectrums of activity. The clinical trial NCT00683865 compared Ofloxacin to Moxifloxacin for the treatment of Pelvic Inflammatory Disease, but they are not the same drug.