Health Condition 1: E088- Diabetes mellitus due to underlying condition with unspecified complications
Conditions
Interventions
Intervention1: Emrok Injection and Emrok Tablet: Product: Emrok Injection (Levonadifloxacin 800 mg/100ml) and emrok Tablet 500 mg
Dose: Emrok Injection 800 mg/100ml or as per PI discretion, emrok oral
or as per PI discretion.
Frequency: Twice a day IV 800 mg/100ml and oral 1000mg twice a day. total duration 28 days and additional 14 days on the basic of PI discretion.
Control Intervention1: Not ap
Sponsors
Wockhardt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject any gender age 18 years or above. 2. subject must be willing to participate in the study and must provide written inform consent
Exclusion criteria
Exclusion criteria: subjects with history of hypersensitivity of drug or same class of drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluate safety profile of EMROK in patients with DFI 2. Incidence of adverse events 3. Overall Global Assessment for Safety on 5 point Likert ScaleTimepoint: At day 4 and day 28 or EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical Success Rate at EOT 2. Clinical Responder Rate / Clinical improvement rate at EOT 3.Clinical Responder Rate / Clinical improvement rate at Early assessment (Day 4±2) 4. Microbiological Success Rate at EOT 5. Overall Global Assessment for EfficacyTimepoint: At day 4 and day 28 or EOT | — |
Countries
India
Contacts
Public ContactDr Kokhan Debnath
Wockhardt Ltd
Outcome results
None listed