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Also known as Floxin
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 oral antibiotic that was studied as a comparator treatment for infected diabetic foot ulcers. In two Phase 3 trials, it was given by mouth and compared against MSI-78 topical cream in patients with infected diabetic ulcers. Both trials have been completed.
Abeona Therapeutics Inc., which trades under the ticker ABEO, is the developer associated with the ofloxacin clinical program in diabetic foot ulcers. The company sponsored the Phase 3 studies evaluating oral ofloxacin against MSI-78 topical cream in patients with infected diabetic ulcers.
Ofloxacin reached Phase 3 development for infected diabetic foot ulcers. Two Phase 3 trials have been completed, and no trials are currently active. The program enrolled a total of 926 patients across the two studies, which were randomized, double blind, and active controlled.
Two completed Phase 3 trials studied ofloxacin in infected diabetic foot ulcers: NCT00563433, which enrolled 342 patients, and NCT00563394, which enrolled 584 patients. Both were conducted in the United States, were randomized and double blind, and compared MSI-78 topical cream with oral ofloxacin.
Ofloxacin is an investigational treatment in this program and has not been established as approved for diabetic foot ulcers. Its development for this indication reached Phase 3, with two completed active-controlled trials, and no trials are currently active.
Ofloxacin was administered orally and compared with MSI-78 topical cream in patients with infected diabetic foot ulcers. Both Phase 3 trials were randomized, double blind, and active controlled, enrolled adults 18 years and older of any sex, and excluded healthy volunteers. Enrollment totaled 926 patients.