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Fexofenadine in Pruritic Skin Disease

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ClinicalTrials.gov Identifier: NCT00261079
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : November 7, 2007
Sponsor:
Information provided by:
Handok Pharmaceuticals Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Pruritus Drug: Fexofenadine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease
Study Start Date : April 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. The change of physician's assessment on pruritic score before and after 7-day treatment.

Secondary Outcome Measures :
  1. Patient visual analogue scale change and Overall satisfaction.


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00261079


Locations
Korea, Republic of
Handok
Seoul, Korea, Republic of
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Study Director: Hyou-Young Rhim, MD Handok Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier: NCT00261079     History of Changes
Other Study ID Numbers: M016455_4125
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: November 7, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs