NCT00812422

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

December 19, 2008

Last Update Submit

January 15, 2010

Conditions

FeverRespiratory Tract Infection

Keywords

Fever due to acute upper respiratory tract infection

Outcome Measures

Primary Outcomes (1)

  • measure reduction in fever

    measure temperature every hour for 3 hours then once again 3 days later

Secondary Outcomes (1)

  • 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).

Study Arms (3)

Dexibuprofen 1

EXPERIMENTAL

Dexibuprofen 2.5 or 5 mg/kg

Drug: Dexibuprofen

Dexibuprofen 2

EXPERIMENTAL

Dexibuprofen 3.5 or 7 mg/kg

Drug: Dexibuprofen

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 5 or 10 mg/kg

Drug: Ibuprofen

Interventions

DexibuprofenDRUG

one dose of Dexibuprofen 2.5 or 5 mg/kg

Dexibuprofen 1
IbuprofenDRUG

one dose of Ibuprofen 5 or 10 mg/kg

Ibuprofen

Eligibility Criteria

Age6 Months - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Common cold with fever
  • Age 6 months to 14 years

You may not qualify if:

  • Gastric ulcer
  • Bleeding tendency
  • Liver disease
  • Kidney disease
  • Hypertension
  • Hypersensitivity to the drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Asan Medical Center

Seoul, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, South Korea

Location

Korea University Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

FeverRespiratory Tract Infections

Interventions

dexibuprofenIbuprofen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Young Yull Koh

    Seoul National University Hospital

    STUDY DIRECTOR

  • Chang-Keun Kim

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

January 18, 2010

Record last verified: 2010-01

Locations

KR(4)