CLINICAL STUDY EVALUATING EFFICACY AND SAFETY OFINTRAMUSCULAR INJECTION OF PARACETAMOL 500MG/ 2ML IN THE MANAGEMENT OF FEVER

Phase 3

Completed

• Conditions: Health Condition 1: R509- Fever, unspecified

• Registration Number: CTRI/2021/01/030201
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Both male and female in the age group of 18-65 years (both inclusive)

Having fever (oral temperature between 101â??104ºF, both inclusive) of

recent onset ( < 3 days) & expected to be hospitalized >= 24 hrs.

Willing to comply with study requirements including periodic

measurements/examinations, laboratory investigations and avoiding

any intramuscular (IM) administration during the entire study

duration of 7 days, as documented by provision of written Informed

Consent prior to participation in the study

Exclusion Criteria

Fever suspected to be due to neurological infection or any cancer.

Patient receiving any IM injection(s) for the co morbid condition and

where the IM injection(s) are expected to continue.

High grade fever ( >104ºF) or suspected septicemia

Hypotension inferred from systolic blood pressure < 90 mmHg

Admission in intensive care unit (ICU) or intensive cardiac care

unit (ICCU)

Severe kidney (creatinine > 2 mg/dl) or liver disease (SGOT &

SGPT > 3 times ULN and based on discretion of the investigator)

Patients with serum CPK levels > 5 times the ULN for that gender

Patients under ongoing treatment with drugs like, statins and fibrates (either alone or in combination), colchicine

Thrombocytopenia, defined as platelets less than 50000/μl

Consumed > 2.5 gram of Paracetamol within last 24 hours before study drug administration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of completed patients achieving oral temperature � 100°F at <br/ ><br>180 ± 15 minutes after study drug administration or before.Timepoint: 15 min 30 min 60 min 90 min 120 min 180 min 240 min 360 min

Secondary Outcome Measures

Name	Time	Method
Mean reduction in oral temperature at each time point compared to baseline <br/ ><br>Proportion of patients administered rescue drug before 180 ± 15 minutes from administration of study drug <br/ ><br>Change in serum CPK levels at the end of 24 hours and 7 days from the baseline, respectively <br/ ><br>Change in serum CPK levels at the end of 7 days from 24 hoursTimepoint: 15 min 30 min 60 min 90 min 120 min 180 min 240 min 360 min