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The Efficacy and Safety of Dexibuprofen Syrup

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812422
First Posted: December 22, 2008
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Inje University
  Purpose
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.

Condition Intervention Phase
Fever Respiratory Tract Infection Drug: Dexibuprofen Drug: Ibuprofen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • measure reduction in fever [ Time Frame: measure temperature every hour for 3 hours then once again 3 days later ]

Secondary Outcome Measures:
  • 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). ]

Enrollment: 260
Study Start Date: February 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexibuprofen 1
Dexibuprofen 2.5 or 5 mg/kg
Drug: Dexibuprofen
one dose of Dexibuprofen 2.5 or 5 mg/kg
Experimental: Dexibuprofen 2
Dexibuprofen 3.5 or 7 mg/kg
Drug: Dexibuprofen
one dose of Dexibuprofen 3.5 or 7 mg/kg
Active Comparator: Ibuprofen
Ibuprofen 5 or 10 mg/kg
Drug: Ibuprofen
one dose of Ibuprofen 5 or 10 mg/kg

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812422


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of
Korea University Hospital
Seoul, Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Inje University
Investigators
Study Director: Young Yull Koh Seoul National University Hospital
Principal Investigator: Chang-Keun Kim Inje University
  More Information

Responsible Party: Chang-Keun Kim, Inje University Sanggye Paik Hospital
ClinicalTrials.gov Identifier: NCT00812422     History of Changes
Other Study ID Numbers: AG_DIBU_2007
First Submitted: December 19, 2008
First Posted: December 22, 2008
Last Update Posted: January 18, 2010
Last Verified: January 2010

Keywords provided by Inje University:
Fever due to acute upper respiratory tract infection

Additional relevant MeSH terms:
Infection
Fever
Respiratory Tract Infections
Body Temperature Changes
Signs and Symptoms
Respiratory Tract Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action