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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2018/05/04
    • Registered Date : 2018/05/22
    • Last Updated Date : 2018/05/04
Background Information
1.Background  
CRIS Registration Number KCT0002888 
Unique Protocol ID YJ9-301 
Public/Brief Title 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 infection 
Scientific Title 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 infection  
Acronym  
MFDS Regulated Study Yes
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number KC13MDMT0120 
Approval Date 2013-02-26 
Institutional Review Board  
- Name IRB, Seoul St.Mary's Hospital  
- Address 222, Banpo-daero, Seocho-gu, Seoul 
- Telephone 02-2258-8202 
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name DaeChul Jeong 
- Title Proffesor 
- Telephone +82-2-2258-6180 
- Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital 
- Address 222, Banpodaero, Seocho-gu, Seoul 
Contact Person for Public Queries
- Name DaeChul Jeong 
- Title Proffesor 
- Telephone +82-2-2258-6180 
- Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital 
- Address 222, Banpodaero, Seocho-gu, Seoul 
Contact Person for Updating Information
- Name DaeChul Jeong 
- Title Proffesor 
- Telephone +82-2-2258-6180 
- Affiliation The Catholic University of Korea, Seoul St. Mary's Hospital 
- Address 222, Banpodaero, Seocho-gu, Seoul 
Status
4. Status Status  
Study Site Multi-center (Number of center : 7)
Overall Recruitment Status Completed  
Date of First Enrollment 2013-07-31 , Actual
Target Number of Participant 322
Primary Completion Date 2016-06-05 , Actual
Study Completion Date 2016-06-05 , Actual
Recruitment Status by Participating Study Site 1 
- Name of Study Site The Catholic University of Korea, Seoul St. Mary's Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2013-09-11 , Actual
Recruitment Status by Participating Study Site 2 
- Name of Study Site The Catholic University of Korea, St. Vincent's Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2013-07-31 , Actual
Recruitment Status by Participating Study Site 3 
- Name of Study Site The Catholic University of Korea, Daejeon St. Mary's Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2014-03-19 , Actual
Recruitment Status by Participating Study Site 4 
- Name of Study Site The Catholic University of Korea, St. Paul's Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2013-08-14 , Actual
Recruitment Status by Participating Study Site 5 
- Name of Study Site The Catholic University of Korea, Incheon St. Mary's Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2013-08-16 , Actual
Recruitment Status by Participating Study Site 6 
- Name of Study Site Yonsei University, Wonju Severance Christian Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2016-03-29 , Actual
Recruitment Status by Participating Study Site 7 
- Name of Study Site The Catholic University of Korea, Bucheon St. Mary's Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2015-03-30 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Yungjin Pharm 
- Organization Type Pharmaceutical Company  
- Project ID YJ9-301 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Yungjin Pharm 
- Organization Type Pharmaceutical Company  
Study Summary
7. Study Summary  
Lay Summary In this clinical trial, Propacetamol or Dexibuprofen was administered to patients with fever due to colds (acute upper respiratory infection) to demonstrate that the test drug is not clinically inferior to the reference drug by assessing the antipyretic efficacy and safety.

Primary objective
Comparison of efficacy between Propacetamol and Dexibuprofen for body temperature reduction by assessing changes in body temperature of patients with fever due to cold (acute upper respiratory infection)

Secondary objective
To compare the efficacy of the two drugs using the maximum reduction in body temperature, the normalization rate, the average time taken for normalization, and the AUC for time-body temperature until 6 hours after administration, etc. and to compare the safety of the two drugs by using adverse reactions and laboratory tests

By proving the safety and efficacy of Propacetamol hydrochloride (1 g) for infants and toddlers, it is possible to obtain approval for infants and toddlers and to make therapeutic use for patients who are unable to take oral medicines.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase3 
Intervention Model Parallel  
Blinding/Masking Double 
Blinded Subject Subject, Investigator 
Allocation RCT 
Intervention Type Drug  
Intervention Description Test group: A weight-normalized dose of test drug + 0.9% normal saline is dosed once intravenously, and at the same time, placebo for the control drug is orally administered once
Control group: 0.9% normal saline is dosed once intravenously, and at the same time, the control drug is orally administered once  
Number of Arms
Arm 1 Arm Label Test group (Propacetamol) 
Target Number of Participant 161 
Arm Type Experimental 
Arm Description Test drug: Propacetamol, Denogan injection, Youngjin Chemical Industry Co., Ltd. Children under 10 kg (approximately under 1 year old): Propacetamol 15 mg / kg Children over 10 kg (approximately over 1 year old): Propacetamol 30 mg / kg 0.9% normal saline solution containing Propacetamol and + Dexibuprofen syrup At a temperature above 38.0 ° C, 100 ml 0.9% normal saline solution containing test drug or 100 ml 0.9% normal saline solution not containing test drug is intravenously instilled for 30 minutes, followed by oral administration of the control drug or placebo of the control drug . For the 0.9% normal saline solution, use the same manufacturer's product (JW Chungwae NS, JW Chungwae Pharmaceutical). 
Arm 2 Arm Label Control group (Dexibuprofen) 
Target Number of Participant 161 
Arm Type Active comparator 
Arm Description Control drug: Dexibuprofen, Maxibupen Syrup 6mg/kg, Hanmi Pharmaceutical 0.9% normal saline solution not containing Propacetamol + maxi buppen syrup At a temperature above 38.0 ° C, 100 ml 0.9% normal saline solution containing test drug or 100 ml 0.9% normal saline solution not containing test drug is intravenously instilled for 30 minutes, followed by oral administration of the control drug or placebo of the control drug . For the 0.9% normal saline solution, use the same manufacturer's product (JW Chungwae NS, JW Chungwae Pharmaceutical). 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of th respiratory system
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 6 Month ~ 14 Year
Description 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  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome clinical-equivalence 
Primary Outcome(s) 1 
- Outcome Reduction of body temperature 
- Timepoint To compare the body temperature reduction bewteen two groups by estimating body temperature of pre-administration and 4 hours after administration 
Secondary Outcome(s) 1 
- Outcome Area-Under-Curve (AUC) of axillary temperature-time cuve from the administration time to 6 hours after administration 
- Timepoint To estimate body temperature of the time point 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after administration 
Secondary Outcome(s) 2 
- Outcome Maximal reduction of the body temperature until 6 hours after administration 
- Timepoint Until 6 hours after administration 
Secondary Outcome(s) 3 
- Outcome the ratio of the body temperature reduction to normal for each test group and the control group from 6 hours after administration 
- Timepoint From 6 hours after administration 
Secondary Outcome(s) 4 
- Outcome the time taken for the body temperature to first decline to normal 
- Timepoint Until 6 hours after administration 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No