| CTRI Number |
CTRI/2024/04/065615 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [PEM] |
| Study Design |
Other |
|
Public Title of Study
|
Prescription event monitoring study of Emrok injection and tab
in the patient of diabetes foot ulcer. |
|
Scientific Title of Study
|
A Prospective, Prescription Event Monitoring (PEM) surveillance of EMROK® &/or EMROK O® in the management of Diabetic Foot Infections. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WOC/EMR/PEM-01/24 Ver.01 date 01 Feb.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Dalvi |
| Designation |
Principal Investigator |
| Affiliation |
Vishal Clinic |
| Address |
Vikrant Society Shop no. 03, ground floor, Manisha Nagar NO. 1 Kalwa (W) Thane-Mumbai
Mumbai
MAHARASHTRA
4000605
India |
| Phone |
8591424924 |
| Fax |
|
| Email |
vishaldalvi1986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPurushotham |
| Designation |
Medical Monitor |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Limited,
Wockhardt Towers
Bandra-Kurla Complex
Bandra – East, Mumbai – 400051
Mumbai
MAHARASHTRA
400 051
India |
| Phone |
919739270420 |
| Fax |
|
| Email |
purushothamVS@wockhardt.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Khokan Debnath |
| Designation |
Senior General Manager (Head) – RA, Clinical Operations, PV and QA (India and Emerging Market) |
| Affiliation |
Wockhardt Ltd |
| Address |
Wockhardt Limited,
Wockhardt Towers
Bandra-Kurla Complex
Bandra – East, Mumbai – 400051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596407 |
| Fax |
|
| Email |
kdebnath@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Ltd Wockhardt Towers
Bandra-Kurla Complex
Bandra – East, Mumbai – 400051
|
|
|
Primary Sponsor
|
| Name |
Wockhardt Ltd |
| Address |
Wockhardt Towers
Bandra-Kurla Complex
Bandra – East, Mumbai – 400051
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal Dalvi |
Vishal Clinic |
Vikrant Society Shop no. 03, ground floor, Manisha Nagar NO. 1 Kalwa (W) Thane-Mumbai
Thane
MAHARASHTRA |
8591424924
vishaldalvi1986@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), D.Y. Patil Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E088||Diabetes mellitus due to underlying condition with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 1000 mg; 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. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
subjects with history of hypersensitivity of drug or same class of drug. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 Scale |
At day 4 and day 28 or EOT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 Efficacy |
At day 4 and day 28 or EOT |
|
|
Target Sample Size
|
Total Sample Size="7500"
Sample Size from India="7500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
23/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective and multi-centric prescription event monitoring (PEM) surveillance in patients who have been prescribed with either EMROK® or EMROK O® or both. Eligible patients will be identified by the investigator / physician based on selection criteria. All the patients must have received EMROK® or EMROK O ® in routine clinical practice at the study site. Data would be collected from the medical records of such patients prospectively. |