Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ofloxacin · 2 trials · 1 indication
a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy
Measure will be a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy
| Arm | Type | Description |
|---|---|---|
| ofloxacin | ACTIVE_COMPARATOR | an oral antibiotic (ofloxacin 400 mg) twice a day and a placebo vehicle topical cream twice a day for 14 days, extended up to 28 days if clinically warranted |
| MSI-78 | ACTIVE_COMPARATOR | an oral placebo twice a day and MSI-78 1%/2% Topical Cream twice a day for 14 days, extended up to 28 days if clinically warranted. |
| Name | Type | Description |
|---|---|---|
| ofloxacin | DRUG | 400 mg twice a day for 14 days |
| MSI-78 | DRUG | 1%/2% topical cream twice a day for 14 days |
Inclusion Criteria: * Non-hospitalized ambulatory patients with diabetes mellitus * Men or Women greater than 18 years old * Patients must be considered reliable, willing and able to give consent * Female patients must be postmenopausal for a least 6 months or surgically sterilized * Localized infe...
Ofloxacin is an investigational small molecule being studied for the treatment of infected diabetic foot ulcers. It is currently in Phase 3 clinical development, though the trials listed are completed. The drug has not been approved for this indication and remains under investigation.
Ofloxacin is being developed by Abeona Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ABEO. The company is conducting clinical research to evaluate the drug's safety and efficacy for treating infected diabetic foot ulcers.
Ofloxacin is in Phase 3 clinical development for the treatment of infected diabetic foot ulcers. Two Phase 3 trials have been completed, with a total enrollment of 926 participants. The drug is investigational and has not been approved by regulatory authorities for this use.
Ofloxacin has been studied in two completed Phase 3 clinical trials: NCT00563394 with 584 participants and NCT00563433 with 342 participants. Both trials compared MSI-78 topical cream versus oral ofloxacin in the treatment of infected diabetic ulcers in the United States.
Ofloxacin is not FDA approved for the treatment of diabetic foot ulcers. It is an investigational drug that has received orphan drug designation from the FDA. The drug is still in clinical development, and its safety and efficacy have not been fully established for this indication.