Fexofenadine in Pruritic Skin Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

December 1, 2005

Last Updated Date

November 5, 2007

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00261079 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patient visual analogue scale change and Overall satisfaction.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Fexofenadine in Pruritic Skin Disease

Official Title ^ICMJE

The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pruritus

Intervention ^ICMJE

Drug: Fexofenadine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

435

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

12 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00261079

Responsible Party

Study ID Numbers ^ICMJE

M016455_4125

Study Sponsor ^ICMJE

Handok Pharmaceuticals Co., Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Hyou-Young Rhim, MD

Handok Pharmaceuticals Co., Ltd.

Information Provided By

Handok Pharmaceuticals Co., Ltd.

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP