The Efficacy and Safety of Dexibuprofen Syrup

January 15, 2010 updated by: Inje University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexibuprofen 1
Dexibuprofen 2.5 or 5 mg/kg
Drug: Dexibuprofen
one dose of Dexibuprofen 2.5 or 5 mg/kg
Drug: Dexibuprofen
one dose of Dexibuprofen 3.5 or 7 mg/kg
Experimental: Dexibuprofen 2
Dexibuprofen 3.5 or 7 mg/kg
Drug: Dexibuprofen
one dose of Dexibuprofen 2.5 or 5 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measure reduction in fever
Time Frame: measure temperature every hour for 3 hours then once again 3 days later
measure temperature every hour for 3 hours then once again 3 days later

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
every hour for 3 hours (unwanted reaction). 3 days later (clinical laboratory test and physical examination).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Study Director: Young Yull Koh, Seoul National University Hospital
  • Principal Investigator: Chang-Keun Kim, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

January 18, 2010

Last Update Submitted That Met QC Criteria

January 15, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG_DIBU_2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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