The Efficacy and Safety of Dexibuprofen Syrup

This study has been completed.
Sponsor:
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT00812422
First received: December 19, 2008
Last updated: January 15, 2010
Last verified: January 2010

December 19, 2008
January 15, 2010
February 2008
May 2009   (final data collection date for primary outcome measure)
measure reduction in fever [ Time Frame: measure temperature every hour for 3 hours then once again 3 days later ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00812422 on ClinicalTrials.gov Archive Site
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). ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Efficacy and Safety of Dexibuprofen Syrup
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Fever
  • Respiratory Tract Infection
  • Drug: Dexibuprofen
    one dose of Dexibuprofen 2.5 or 5 mg/kg
  • Drug: Dexibuprofen
    one dose of Dexibuprofen 3.5 or 7 mg/kg
  • Drug: Ibuprofen
    one dose of Ibuprofen 5 or 10 mg/kg
  • Experimental: Dexibuprofen 1
    Dexibuprofen 2.5 or 5 mg/kg
    Intervention: Drug: Dexibuprofen
  • Experimental: Dexibuprofen 2
    Dexibuprofen 3.5 or 7 mg/kg
    Intervention: Drug: Dexibuprofen
  • Active Comparator: Ibuprofen
    Ibuprofen 5 or 10 mg/kg
    Intervention: Drug: Ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
260
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
6 Months to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00812422
AG_DIBU_2007
Yes
Chang-Keun Kim, Inje University Sanggye Paik Hospital
Inje University
Not Provided
Study Director: Young Yull Koh Seoul National University Hospital
Principal Investigator: Chang-Keun Kim Inje University
Inje University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP