The Efficacy and Safety of Dexibuprofen Syrup | NCT00812422

Studies
The Efficacy and Safety of Dexibuprofen Syrup

NCT00812422

Sponsor

Inje University

Status

Completed

Last Update Posted

Jan 18, 2010Estimated

Enrollment

260Actual

Phase

Phase 3

Conditions

Fever
Respiratory Tract Infection

Interventions

Dexibuprofen
Dexibuprofen
Ibuprofen

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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)

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Dec 19, 2008

First Submission Date that Met QC Criteria

Dec 19, 2008

First Posted Date

Dec 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2010

Last Update Posted Date

Jan 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

260Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dexibuprofen	Drug	one dose of Dexibuprofen 2.5 or 5 mg/kg	Dexibuprofen 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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).

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young Yull Koh	Seoul National University Hospital	Study Director
Chang-Keun Kim	Inje University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea
Inje University Sanggye Paik Hospital

Condition Browse Module

MeSH Terms

ID	Term
D005334	Fever
D012141	Respiratory Tract Infections

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C539402	dexibuprofen
D007052	Ibuprofen

Ancestor Terms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided