Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Propacetamol Compared to Dexibuprofen in patients with Acute upper respiratory tract infectio

Not Applicable

Completed

Conditions: Diseases of th respiratory system

Registration Number: KCT0002888

Lead Sponsor: Yungjin Pharm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 322

Inclusion Criteria

Selection Criteria
Patients who meet the following criteria should be selected.
1) Children 6 months to 14 years old
2) fever due to cold (acute upper respiratory infection) (=38 ?)
3) The applicant or who has a written consent of his / her parent (legal representative)

Exclusion Criteria

Exclusion criteria
Patients who meet the conditions described below are excluded from the study.
1) Those taking antipyretic drugs within 4 hours
2) Those who had a febrile crisis within the last 6 months
3) Patients with severe blood disorders
4) Those with a medical history of kidney, liver, lung, endocrine, hematology, and heart, but who are within 6 months of termination of treatment
5) Those with neurologic or CNS disorders
6) Diabetic patients, currently unregulated status
7) Those suspected of having respiratory diseases caused by lower respiratory tract infection
8) Patients who participated in other clinical trial drug studies within the previous 4 weeks
9) Severe hemolytic anemia patients
10) Patients undergoing maintenance therapy for bronchial asthma
11) Those with asthma, urticaria or allergic reactions to aspirin or NSAIDs
12) A person who is not suitable for participation in the clinical trial, for either physically and mentally, judged by the examiner

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of body temperature

Secondary Outcome Measures

Name	Time	Method
Area-Under-Curve (AUC) of axillary temperature-time cuve from the administration time to 6 hours after administration;Maximal reduction of the body temperature until 6 hours after administration;the ratio of the body temperature reduction to normal for each test group and the control group from 6 hours after administration;the time taken for the body temperature to first decline to normal