Health Condition 1: R509- Fever, unspecified
Conditions
Interventions
Intervention1: Paracetamol 500mg/ 2 ml manufactured by
Troikaa Pharmaceuticals Ltd.: single-dose of 2 ml injection of the test
product is to be injected intramuscularly deep in to the upper and outer
Sponsors
Troikaa Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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 ( = 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of completed patients achieving oral temperature â?¤ 100°F at 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
| Measure | Time frame |
|---|---|
| Mean reduction in oral temperature at each time point compared to baseline Proportion of patients administered rescue drug before 180 ± 15 minutes from administration of study drug Change in serum CPK levels at the end of 24 hours and 7 days from the baseline, respectively 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 | — |
Countries
India
Contacts
Public ContactPratik Shah
Troikaa Pharmaceuticals ltd
Outcome results
None listed