| CTRI Number |
CTRI/2025/01/078895 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on the Safety and Effectiveness of Meftal-P Suspension for Treating Fever in Children |
|
Scientific Title of Study
|
An observational study to evaluate the efficacy and safety of Mefenamic acid (Meftal-P Suspension) in children with febrile illness |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vanasnt M Khalatkar |
| Designation |
Consultant Pediatrician |
| Affiliation |
Khalatkar Hospital |
| Address |
Kurve Hospital,537,Sakkardara Road, Nagpur 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
09823044438 |
| Fax |
|
| Email |
vasant.khalatkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanasnt M Khalatkar |
| Designation |
Consultant Pediatrician |
| Affiliation |
Khalatkar Hospital |
| Address |
Kurve Hospital,537,Sakkardara Road, Nagpur 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
09823044438 |
| Fax |
|
| Email |
vasant.khalatkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanasnt M Khalatkar |
| Designation |
Consultant Pediatrician |
| Affiliation |
Khalatkar Hospital |
| Address |
Kurve Hospital,537,Sakkardara Road, Nagpur 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
09823044438 |
| Fax |
|
| Email |
vasant.khalatkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Khalatkar Hospital, Kurve Hospital,537,Sakkardara Road, Nagpur 440024 |
|
|
Primary Sponsor
|
| Name |
Dr. Vasant M. Khalatkar |
| Address |
Kurve Hospital, 537, Sakkardara Road, Nagpur-440024 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Vanasnt M Khalatkar |
Khalatkar Hospital |
Room No. 01, OPD, Khalatkar Hospital, Kurve Hospital 537, Sakkardara Road, Nagpur, 440042, Maharashtra
Nagpur
MAHARASHTRA |
09823044438
vasant.khalatkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Khalatkar Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J100||Influenza due to other identifiedinfluenza virus with pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MEFTAL-P Suspension (100 mg/5 mL of Mefenamic Acid)
|
Meftal-P will be prescribed for 3 times a day daily dose for 3 days.
Recommended dosage based on age group
6 months to 2 years: 2.5 ml three times daily
Greater than 2 to 6 years: 5 ml three times daily
Greater than 6 to 12 years: 5 ml to 10 ml three times daily (depending on body weight) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females aged 6 months to less than 18 years.
2.Subject diagnosed with febrile illness i.e., fever ranging between (100.5°F – 104°F).
3.Subject can consume oral medication.
4.Able to give oral/written assent/parental consent from a parent/guardian. |
|
| ExclusionCriteria |
| Details |
1.Subjects who have used acetaminophen within 6 hours or ibuprofen, aspirin, or other NSAIDs within 8 hours prior to screening.
2.Subjects with Hypersensitivity to Mefenamic Acid or NSAIDs.
3.History of renal, hepatic impairment, diabetes mellitus, or thrombocytopenia.
4.Moderate or severe dehydration.
5.Severe underlying illness that contraindicates study participation (e.g., kidney disease, etc.)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of Mefenamic Acid (MEFTAL-P Suspension) at the standardized dose of (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects.
2. To assess the safety and tolerability of standardized dosing of mefenamic acid (5 mg/kg) in treating febrile illness in pediatric and adolescent subjects. |
To measure the percentage reduction in fever from
baseline (Day 1) at three daily time points (morning, noon, and night)
over the 3-day treatment period.
Baseline (Day 1) to Day 3
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety profile, monitor adverse events, and
determine the time required to achieve sustained normothermia
(normal body temperature)
The following are the secondary objectives of the study
1 To monitor AEs,SAEs.
2 To determine the time required to achieve sustained normothermia (normal Body Temperature) |
Baseline (Day 1) to Day 7
Body temperature will be monitored daily during the 3-
day treatment period, with follow-up on Day 3 and Day 7. The time
it takes for the subject to maintain normal body temperature without
fever for a full 24 hours will be recorded. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
29/01/2025 |
| Date of Study Completion (India) |
11/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 clinical study to evaluate the efficacy and safety of Mefenamic Acid (Meftal-P Suspension) in Children with Febrile illness. Symptomatic treatment of fever in pediatric and adolescent subjects aged 6 months to <18 years. A total of 50 subjects aged 6 months to <18 years with febrile illness will be enrolled and dose of 5mg/kg of body weight thrice a day for 3 days will be prescribed to be taken thrice daily, orally. Visit-2 will be on Day 3 and study related assessments will be performed. And Visit-3 (Day 7) will be the end of the study visit and all the relevant study related procedures will be performed as per the study protocol. |