Health Condition 1: R509- Fever, unspecified
Conditions
Interventions
Intervention1: SUMO-L Fast 650 tablet
Dose: 650 mg(1 tablet),
Frequency: Once (single dose),
Route of administration: Oral
Duration: Once for one day
: Route/mode of administration: Oral, with wate
Sponsors
Alkem Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 60 years (both inclusive) 2. Body temperature (oral) greater than equal to 38 degree celsius (greater than equal to 100.4degree Fahrenheit), with or without associated pain 3. Symptom onset within 72 hours preceding screening 4. Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Known allergy/ hypersensitivity/ contraindications to paracetamol/acetaminophen 2. Fever/pain caused due to chronic clinical conditions (e.g., osteoarthritis, tuberculosis, malignancy, etc.) 3. Known liver dysfunction, defined as raised alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels or levels of ALT/ AST greater than 2 times the upper limit of normal (ULN) based on lab reports within 1 month prior to screening or as per Investigators judgement 4. Use of any antipyretic or analgesic within 12 hours prior to screening 5. Requirement of hospitalization at baseline 6. Pregnant or lactating women 7. Refusal or inability to comply with the requirements of the protocol for any reason, including stay at study site for data accrual till 90 2 min post single dose administration and answering questionnaires 8. Any other condition(s) in the individual which, in the opinion of the Investigator, could confound the results of the trial, put the patient at undue risk, or make the patient unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in body temperature (oral) 2. Rate of fall of baseline body temperature (defined as decrease in temperature per minute) 3. Time to greater than equal to 1 C reduction in baseline body temperature (oral)Timepoint: 1.baseline, 10, 15, 20, 30, 45, 60, and 90 min 2. Baseline to 90 min 3. Baseline to 90 min | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain score based on the NRS scaleTimepoint: baseline, 10, 15, 20, 30, 45, 60, and 90 min;Rate of decrease of baseline pain score (defined as decrease in pain score per minute)Timepoint: Baseline to 90 min;Time to greater than equal to 30% reduction in baseline NRS scoreTimepoint: Baseline to 90 min;Time to fever resolution (defined as body temperature less than equal to 37 C or less than equal to 98.6 F)Timepoint: Baseline to 90 min;Proportion of patients achieving complete fever resolution (less than equal to 37 C or less than equal to 98.6 F) at 90 minTimepoint: 90 min;Proportion of patients with greater than equal to 30% reduction in baseline NRS scoreTimepoint: 10, 15, 20, 30, 45, 60, and 90 min;Time to pain resolution (defined as NRS score of 0)Timepoint: Baseline to 90 min;Proportion of patients achieving complete pain resolution (defined as attainment of NRS score of 0)Timepoint: 90 min;Proportion of patients with treatment satisfaction for resolution of febrile or febrile-pain conditions (based on a 5-point Likert scale: 1=very unsatisfied, 2=unsatisfied 3=neutral, 4=satisfied, 5=very satisfied)Timepoint: 90 min;Proportion of participants with AEs and SAEsTimepoint: Baseline to 90 min | — |
Countries
India
Contacts
Public ContactDr Amitrajit Pal
Alkem Laboratories Ltd.
Outcome results
None listed