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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

Status Approved

First Submitted Date

2018/05/04
Registered Date

2018/05/22
Last Updated Date

2018/05/04

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
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

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC13MDMT0120
Approval Date	2013-02-26
Institutional Review Board Name	IRB, Seoul St.Mary's Hospital
Institutional Review Board Address	222, Banpo-daero, Seocho-gu, Seoul
Institutional Review Board Telephone	02-2258-8202
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
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

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
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
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2013-09-11 ,
Recruitment Status by Participating Study Site 2
Name of Study	The Catholic University of Korea, St. Vincent's Hospital
Recruitment Status	Completed
Date of First Enrollment	2013-07-31 ,
Recruitment Status by Participating Study Site 3
Name of Study	The Catholic University of Korea, Daejeon St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2014-03-19 ,
Recruitment Status by Participating Study Site 4
Name of Study	The Catholic University of Korea, St. Paul's Hospital
Recruitment Status	Completed
Date of First Enrollment	2013-08-14 ,
Recruitment Status by Participating Study Site 5
Name of Study	The Catholic University of Korea, Incheon St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2013-08-16 ,
Recruitment Status by Participating Study Site 6
Name of Study	Yonsei University, Wonju Severance Christian Hospital
Recruitment Status	Completed
Date of First Enrollment	2016-03-29 ,
Recruitment Status by Participating Study Site 7
Name of Study	The Catholic University of Korea, Bucheon St. Mary's Hospital
Recruitment Status	Completed
Date of First Enrollment	2015-03-30 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Yungjin Pharm
Organization Type	Pharmaceutical Company
Project ID	YJ9-301

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yungjin Pharm
Organization Type	Pharmaceutical Company

7. Study Summary

Study Summary Information
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 Summary Information

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.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
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	2
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).

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (J00-J99)Diseases of the respiratory system (J00)Acute nasopharyngitis[common cold]
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 6Month~14Year
	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

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	clinical-equivalence
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

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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