The Efficacy and Safety of Dexibuprofen Syrup

Fever Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812422
• Other study ID #: AG_DIBU_2007
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2008
• Last updated: January 15, 2010
• Start date: February 2008
• Est. completion date: May 2009

Study information

• Verified date: January 2010
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fever
• Infection
• Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Drug:
• Dexibuprofen
one dose of Dexibuprofen 2.5 or 5 mg/kg
• Dexibuprofen
one dose of Dexibuprofen 3.5 or 7 mg/kg
• Ibuprofen
one dose of Ibuprofen 5 or 10 mg/kg

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure reduction in fever		measure temperature every hour for 3 hours then once again 3 days later	No
Secondary	determine safety of dexibuprofen by unwanted reaction, clinical laboratory test and physical examination.		every hour for 3 hours (unwanted reaction). 3 days later (clinical laboratory test and physical examination).	Yes