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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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). ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Months to 14 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812422

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea University Hospital
Seoul, Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of
Inje University Sanggye Paik 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

No publications provided

Responsible Party: Chang-Keun Kim, Inje University Sanggye Paik Hospital
ClinicalTrials.gov Identifier: NCT00812422     History of Changes
Other Study ID Numbers: AG_DIBU_2007
Study First Received: December 19, 2008
Last Updated: January 15, 2010
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014