fever
Conditions
Interventions
Experimental group:JC242 Tablets (Arginine Ibuprofen Tablets)
Control group 2:Paracetamol Tablets
Control group 1:Dexibuprofen Tablets
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged from 18 to 65 years old (inclusive of the critical values), both males and females are eligible; 2.Body Mass Index (BMI): 18.5 = 38.5 °C at screening; (If antipyretics have been taken prior to screening, the interval between the last dose and randomization shall be more than 4 hours, with axillary temperature still >= 38.5 °C); 5.Disease course within 48 hours at screening; (Onset of disease: defined as the occurrence of any one or more of the following symptoms: initial fever (axillary temperature >= 37.3 °C), pharyngeal redness and swelling with pain, cough, nasal congestion or purulent nasal discharge); 6.Voluntary participation in the trial and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients who have used antipyretic drugs within 4 hours prior to randomization (including other non-steroidal anti-inflammatory drugs such as paracetamol, indomethacin, naproxen, nabumetone, diclofenac, nimesulide, rofecoxib, celecoxib; or chlorpromazine, traditional Chinese medicines, etc.); 2.Patients with allergy to ibuprofen and other non-steroidal anti-inflammatory drugs, paracetamol or arginine; 3.Patients with abnormal hepatic and renal function (ALT, AST >= 3 ULN; Cr >= 1.5 ULN) or patients undergoing dialysis. (Hepatic and renal function tests shall be performed before enrollment; randomization is allowed without waiting for test results provided that the patient denies a history of abnormal hepatic and renal function); 4.Patients with non-infectious fever, such as fever caused by hematological diseases, drug-induced fever, neurogenic fever, or malignant tumor-related fever; 5.Patients with non-infectious fever, such as fever caused by hematological diseases, drug-induced fever, neurogenic fever, or malignant tumor-related fever; 6.Patients with a history of peptic ulcer or gastrointestinal bleeding requiring treatment within 6 weeks prior to randomization; 7.Patients with severe cardiovascular diseases or cardiovascular disease risk (AHA classification >= Class B); 8.Patients receiving treatment with methotrexate, warfarin, lithium preparations, ACE inhibitors and diuretics; 9.Patients who have received systemic glucocorticoids (e.g., prednisone, dexamethasone, methylprednisolone, etc.) within 7 days prior to randomization, or those expected to require systemic glucocorticoid therapy during the study period; 10.Pregnant or lactating women, or those planning pregnancy within 3 months; 11.Patients who have participated in other clinical drug trials within 3 months; 12.Other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the temperature-time curve within 4 hours after the first administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects experiencing treatment failure (temperature reduction < 0.5 °C) at 4 hours post-dose;Proportion of subjects with a 0.5 °C temperature reduction within 4 hours after the first dose;Area under the temperature-time curve (AUC) within 24 hours after the first dose;Frequency of medication administration and dosing intervals within 24 hours;Area under the temperature-time curve (AUC) within 8 hours after the first dose;Area under the temperature-time curve (AUC) within 4 hours after the first dose;Time to a 0.5 °C temperature reduction in subjects following the first dose; | — |
Countries
China
Contacts
Public ContactYang Song
China-Japan Friendship Hospital
Outcome results
None listed