| CTRI Number |
CTRI/2020/06/026048 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Febrex Plus Drop |
|
Scientific Title of Study
|
Prescriber Based, Post Marketing Surveillance Study (PMS) to generate safety and efficacy data of Febrex Plus Drop |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Indoco/PMS/FEBREX PLUS DROPS/102019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudeep Kumar Patra |
| Designation |
Head Operations |
| Affiliation |
CRO PHARMATRENDZ PRIVATE LIMITED |
| Address |
BJB NAGAR
BHUBANESWAR
PLOT NUMBER F 29
Near Radhakrushna Temple
BJB NAGAR
BHUBANESWAR
Khordha
ORISSA
751014
India |
| Phone |
9861268508 |
| Fax |
|
| Email |
sudeep@pharmatrendz.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saiprasanna Behera |
| Designation |
Director |
| Affiliation |
CRO PHARMATRENDZ PRIVATE LIMITED |
| Address |
BJB NAGAR
BHUBANESWAR
PLOT NUMBER F 29
Near Radhakrushna Temple
BJB NAGAR
BHUBANESWAR
Khordha
ORISSA
751014
India |
| Phone |
9861252518 |
| Fax |
|
| Email |
behera.saiprasanna82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Hiware |
| Designation |
Business Development |
| Affiliation |
Indoco Remedies Limited |
| Address |
R 92 93
TTC MIDC Industrial Area
Thane Belapur Road
Rabale
Navi Mumbai
R 92 93
TTC MIDC Industrial Area
Thane Belapur Road
Rabale
Navi Mumbai
400701
Mumbai
MAHARASHTRA
400701
India |
| Phone |
|
| Fax |
|
| Email |
rahulhiware2017@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indoco Remedies Limited |
| Address |
R 92 93
TTC MIDC Industrial Area
Thane Belapur Road
Rabale
Navi Mumbai
400701 |
| 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 Arakhita Swain |
Pediatric Clinic |
Near Radhakrushna Temple
BJB NAGAR
BHUBANESWAR
Khordha
ORISSA |
7978165987
swainarakhita58@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Febrex Plus Drop
|
twice for three days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex of age 00 to 02 years [both inclusive]
2. Willing to give written informed consent
3. All patients clinically manifesting with symptoms of common cold & cough
|
|
| ExclusionCriteria |
| Details |
1) Patients known, or thought to be hypersensitivity to study drug
2) History of auto-immune disease
3) Concurrent use of corticosteroids
4) Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
5) Participation in other clinical trials the last three months and during study participation
6) Patients with history of epilepsy, or those at risk for seizures or taking seizure drugs
7) Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control
8) Patients with galactose or fructose intolerance
9) Patients with severe renal impairment, including those receiving dialysis.
10) Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
11) Patients with preexisting gallbladder disease
12) Active peptic ulcer disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To generate safety data of Febrex Plus Drops |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To generate efficacy data of Febrex Plus Drops |
5 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/07/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The common cold and influenza are among the most
frequent of illnesses and a cure, at least for the cold, is still some way off.
However, for the most part both are relatively mild and self-limiting
conditions with a well-defined range of symptoms. Therefore, for most
individuals, a reduction in symptom severity is a reasonable substitute for
outright cure.
The aim of this prescriber based post marketing
surveillance is to assess efficacy & safety of Febrex Plus Drops in the actual field conditions of use.
All patients
clinically manifesting with symptoms of common cold & cough and
who have been prescribed Febrex Plus Drops in the recommended dose of
will be assessed for efficacy and safety. Patients will usually be called for
follow-up on the day convenient to them
and will be judged on the bases of
enquiry & clinician impression.
Adverse event reporting will be done using PMS form
supplied by Medical Representative. Patients will be questioned about any
adverse experience during the treatment period (Both anticipated and unexpected side effects) |