Back to resultsThe Efficacy and Safety of Dexibuprofen Syrup
Primary Purpose
Fever, Respiratory Tract Infection
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexibuprofen
Dexibuprofen
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Fever focused on measuring Fever due to acute upper respiratory tract infection
Eligibility Criteria
Inclusion Criteria:
- Common cold with fever
- Age 6 months to 14 years
Exclusion Criteria:
- Gastric ulcer
- Bleeding tendency
- Liver disease
- Kidney disease
- Hypertension
- Hypersensitivity to the drug
Sites / Locations
- Asan Medical Center
- Inje University Sanggye Paik Hospital
- Korea University Hospital
- Kyung Hee University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Dexibuprofen 1
Dexibuprofen 2
Ibuprofen
Arm Description
Dexibuprofen 2.5 or 5 mg/kg
Dexibuprofen 3.5 or 7 mg/kg
Ibuprofen 5 or 10 mg/kg
Outcomes
Primary Outcome Measures
measure reduction in fever
Secondary Outcome Measures
determine safety of dexibuprofen by unwanted reaction, clinical laboratory test and physical examination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00812422
Brief Title
The Efficacy and Safety of Dexibuprofen Syrup
Official Title
Multi-center, Randomized, Double Blinded (Double-dummy), Active-Controlled Parallel-group Comparative, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Dexibuprofen Syrup Compared to Ibuprofen Syrup in Patients With Fever of Common Cold (Acute Upper Respiratory Infection)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Inje University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and efficacy of dexibuprofen syrup and ibuprofen syrup in patients with fever due to common cold.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Respiratory Tract Infection
Keywords
Fever due to acute upper respiratory tract infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexibuprofen 1
Arm Type
Experimental
Arm Description
Dexibuprofen 2.5 or 5 mg/kg
Arm Title
Dexibuprofen 2
Arm Type
Experimental
Arm Description
Dexibuprofen 3.5 or 7 mg/kg
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 5 or 10 mg/kg
Intervention Type
Drug
Intervention Name(s)
Dexibuprofen
Intervention Description
one dose of Dexibuprofen 2.5 or 5 mg/kg
Intervention Type
Drug
Intervention Name(s)
Dexibuprofen
Intervention Description
one dose of Dexibuprofen 3.5 or 7 mg/kg
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
one dose of Ibuprofen 5 or 10 mg/kg
Primary Outcome Measure Information:
Title
measure reduction in fever
Time Frame
measure temperature every hour for 3 hours then once again 3 days later
Secondary Outcome Measure Information:
Title
determine safety of dexibuprofen by unwanted reaction, clinical laboratory test and physical examination.
Time Frame
every hour for 3 hours (unwanted reaction). 3 days later (clinical laboratory test and physical examination).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Common cold with fever
Age 6 months to 14 years
Exclusion Criteria:
Gastric ulcer
Bleeding tendency
Liver disease
Kidney disease
Hypertension
Hypersensitivity to the drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Yull Koh
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chang-Keun Kim
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Inje University Sanggye Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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The Efficacy and Safety of Dexibuprofen Syrup
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