Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Fexofenadine in Pruritic Skin Disease

This study has been completed.
Sponsor:
Information provided by:
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00261079
First received: December 1, 2005
Last updated: November 5, 2007
Last verified: November 2007

December 1, 2005
November 5, 2007
April 2005
Not Provided
The change of physician's assessment on pruritic score before and after 7-day treatment.
Not Provided
Complete list of historical versions of study NCT00261079 on ClinicalTrials.gov Archive Site
Patient visual analogue scale change and Overall satisfaction.
Not Provided
Not Provided
Not Provided
 
Fexofenadine in Pruritic Skin Disease
The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pruritus
Drug: Fexofenadine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
435
October 2006
Not Provided

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.
Both
12 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00261079
M016455_4125
No
Not Provided
Handok Pharmaceuticals Co., Ltd.
Not Provided
Study Director: Hyou-Young Rhim, MD Handok Pharmaceuticals Co., Ltd.
Handok Pharmaceuticals Co., Ltd.
November 2007

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