Comparing two paracetamol formulations for the taste and effectiveness in children with fever

Phase 4

Conditions: Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services

Registration Number: CTRI/2024/04/065184

Lead Sponsor: Pulse Pharmaceuticals Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

i.Male and female subjects from the age of =3 years to 12 years (both inclusive) are eligible to participate in the study.

ii.Only participants requiring treatment on an outpatient basis will be recruited.

iii.The body temperature should be at least 38.5°C/ 101.3°F, with an upper boundary of 40°C/ 104°F associated with various pathologies such as sore throat, influenza, respiratory tract infection, ear infection or immunization.

iv.Parents of all patients will provide signed Informed Consent and patients in the age group of 7-12 will give their own consent along with that of their parents’.

Exclusion Criteria

i.Hypersensitivity to any of the study drug constituents.

ii.A history of any condition that interfered with the absorption, distribution, metabolism or excretion of the study drug.

iii.Patients with hepatic failure.

iv.Patients with previous history of febrile convulsions.

v.Patients, who had received treatment with an antipyretic drug up to 6 hours before inclusion, or treatment with antibiotic therapy in the 12 hours before the start of the trial, are also excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare reduction in fever after administration of two different formulations from baseline at 30 minutes 1 2 3 4 5 6 8 12 and 24 hours post-dosing <br/ ><br>To evaluate the taste acceptability of two different formulations by the child or childs parents or the minder, measured using a Hedonic Rating Scale <br/ ><br>To Document any adverse events occurring during the course of the study.Timepoint: baseline, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 12 hour & 24 hours

Secondary Outcome Measures

Name	Time	Method
To document need for an additional dose or rescue medicationTimepoint: baseline, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 6 hour, 8 hour, 12 hour & 24 hours