Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00563394 | MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers | PHASE3 | COMPLETED | 584 | — | — | Aug 1, 1994 | Jul 1, 1996 | Sep 3, 2020 | 1 | United States |
| NCT00563433 | MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers | PHASE3 | COMPLETED | 342 | — | — | Aug 1, 1994 | Jul 1, 1996 | Sep 3, 2020 | 1 | United States |
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...