Fexofenadine in Pruritic Skin Disease | NCT00261079

Studies
Fexofenadine in Pruritic Skin Disease

NCT00261079

Sponsor

Handok Inc.

Status

Completed

Last Update Posted

Nov 7, 2007Estimated

Enrollment

435Actual

Phase

Phase 4

Conditions

Pruritus

Interventions

Fexofenadine

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

Status Module

Record Verification Date

Nov 2007

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

Apr 2005

Primary Completion Date

Not provided

Completion Date

Oct 2006Actual

First Submitted Date

Dec 1, 2005

First Submission Date that Met QC Criteria

Dec 1, 2005

First Posted Date

Dec 2, 2005Estimated

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

Nov 5, 2007

Last Update Posted Date

Nov 7, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Primary objective:

To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease

Secondary objective:

To evaluate patient's satisfaction of Allegra treatment

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

435Actual

Name	Type	Description	Arm Group Labels	Other Names
Fexofenadine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change of physician's assessment on pruritic score before and after 7-day treatment.

Secondary Outcomes

Measure	Description	Time Frame
Patient visual analogue scale change and Overall satisfaction.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

All patients diagnosed with atopic dermatitis, contact dermatitis

Exclusion Criteria:

Other skin disease except atopic dermatitis, contact dermatitis.
Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day.
Pruritus localized only head and face
Subjects with severe hepatic, renal, heart dysfunction.
Subjects with history of alcohol and drug abuse.
Pregnant and lactating women.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hyou-Young Rhim, MD	Handok Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D011537	Pruritus

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided