| CTRI Number |
CTRI/2021/12/039023 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
28/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post marketing
study to evaluate the Safety and Efficacy of Wikoryl Oral Suspension in children |
|
Scientific Title of Study
|
A Multi-centric, Non-Randomized, Open label, Non-Comparative, Active post marketing
surveillance to evaluate the Safety and Efficacy of Wikoryl Oral Suspension in children of
common cold with fever or allergic rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AL-WK-21-001 Version 1.0 Dated 8/Dec/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradip N Gore |
| Designation |
Senior Manager - Medical Services |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Alembic Pharmaceuticals Limited,
2nd Floor, Prime Corporate Park
Behind ITC Grand Maratha Sheraton, Sahar Road,
Andheri East
Mumbai MAHARASHTRA 400099 India |
| Phone |
9923404398 |
| Fax |
|
| Email |
Pradip.gore@alembic.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pradip N Gore |
| Designation |
Senior Manager - Medical Services |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Alembic Pharmaceuticals Limited,
2nd Floor, Prime Corporate Park
Behind ITC Grand Maratha Sheraton, Sahar Road,
Andheri East
Mumbai MAHARASHTRA 400099 India |
| Phone |
9923404398 |
| Fax |
|
| Email |
Pradip.gore@alembic.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Pradip N Gore |
| Designation |
Senior Manager - Medical Services |
| Affiliation |
Alembic Pharmaceuticals Limited |
| Address |
Alembic Pharmaceuticals Limited,
2nd Floor, Prime Corporate Park
Behind ITC Grand Maratha Sheraton, Sahar Road,
Andheri East
Mumbai MAHARASHTRA 400099 India |
| Phone |
9923404398 |
| Fax |
|
| Email |
Pradip.gore@alembic.co.in |
|
|
Source of Monetary or Material Support
|
| Alembic Pharmaceuticals Ltd. (2nd floor, Prime Corporate Park, Behind ITC Grand Maratha Sheraton, Sahar Road, Andheri (E), Mumbai - 400 099, India |
|
|
Primary Sponsor
|
| Name |
Alembic Pharmaceuticals Limited |
| Address |
2nd Floor, Prime Corporate Park
Behind ITC Grand Maratha Sheraton, Sahar Road,
Andheri East, Mumbai, Maharashtra 400099 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhishek T Chavan |
Jeevan Rekha Hospital |
Clinical Research Room , 3rd Floor, Jeevan Rekha Hospital, Dr. BR Ambedkar road, Opp Civil Hospital Belgaum KARNATAKA |
9113222185
dr.abhishektchavan@gmail.com |
| Dr V N Tripathi |
Prakhar Hospital Pvt. Ltd. |
Clinical Research Department, 4th Floor, Prakhar Hospital, 8/219, Arya Nagar, Kanpur Kanpur Nagar UTTAR PRADESH |
9415050777
dr.vntripathicr@gmail.com |
| Dr Madhav Pandya |
SMVS Swaminarayan Hospital |
Paediatric OPD, SMVS Hospital, Gandhinagar-Ahmedabad Road,
Besides Swaminarayan Dham
Gandhinagar GUJARAT |
9662203454
drmadhavcr@gmail.com |
| Dr Rajib Ray |
Sparsh Hospital and Critical care |
Research Room, Ground Floor, Sparsh Hospitals and Critical Care (P) Ltd, A/407, Sahid Nagar, Bhubaneswar Khordha ORISSA |
8249771669
drrajib207@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee of Prakhar Hospital |
Approved |
| Institutional Ethics Committee Jeevan Rekha Hospital |
Approved |
| Institutional Ethics Committee Sparsh Hosital |
Approved |
| Institutional Ethics Committee Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of
Paracetamol 125 mg, Phenylephrine
Hydrochloride 5 mg, Chlorpheniramine
Maleate 1 mg per 5 ml. |
5ml - 10 ml 3 to 4 times a day for 5 days |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 2-12 years of age. (6 -40 Kg body weight)
2. Genders Eligible for Study: both Males and Females
3. Patients with confirmed clinical diagnosis of Common cold with fever or allergic rhinitis.
4. Patients whose guardians can adhere to the Protocol |
|
| ExclusionCriteria |
| Details |
1. Patients known to be hypersensitive to investigational product
2. Patients with severe hepatic or renal dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of Wikoryl Oral Suspension |
Day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in symptom scores for fever, rhinorrhea, nasal congestion and sneezing |
Day 6 |
|
|
Target Sample Size
|
Total Sample Size="240" Sample Size from India="240"
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)
|
05/01/2022 |
| 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="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It will be a Multicentric, Non-Randomized, Open label, Non-Comparative, Active PMS to evaluate the Safety and efficacy of Wikoryl Oral Suspension, FDC of Paracetamol 125 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 1 mg, per 5 ml in children suffering from Common cold with fever or allergic rhinitis. The active PMS will be conducted for the duration of 5 days by the investigator. At day 1 (baseline) the patient’s guardian will be informed about the study procedure and if agreed then his/ her sign on the informed consent form will be taken and patient will be recruited for the active PMS of Wikoryl Oral suspension. Based on the prescription of the principle investigator the guardians of the patient will give the patient the required medication for the period of 5 days starting from day 1 (visit 1). Also patient’s guardians will be asked to visit to the clinical trial site along with the patient at day 6 for safety and efficacy assessment. Symptom assessment at baseline and visit 2, will be done by principle investigator by measuring the symptom scores for fever, rhinorrhea, nasal congestion and sneezing on a four-point Likert scale for intensity (severity): 0= no symptom, 1 = mild, 2= moderate and 3= severe. Fever is characterized as 0= No fever (< 100.4), 1=Mild/low-grade fever (100.5–102.2 F) ,2=Moderate grade fever (102.2–104.0 F), 3= High grade fever High-grade (104.1–106.0 F). |