Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU) (AUD2OCU)

May 30, 2012 updated by: K. Weller, Charite University, Berlin, Germany

An Exploratory Phase III, Randomised, Double-blind, Therapeutic Single Dose-related Effect, Parallel Group Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)

The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography, volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Allergie-Centrum-Charité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
  2. Patients must exhibit spontaneous urticaria lesions in the randomization visit.
  3. History of beneficial effects of antihistaminic treatment.
  4. Age between 18 and 60 years.
  5. Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised (for details please see protocol).
  6. Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised.
  7. Voluntarily signed written informed consent.

Exclusion Criteria:

  1. The presence of permanent severe diseases, especially those affecting the immune system, except CU.
  2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the gastrointestinal tract).
  3. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
  4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
  5. Evidence of severe renal dysfunction
  6. Evidence of significant hepatic disease (liver enzymes twice the upper reference value).
  7. The presence of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.
  8. History of adverse reactions including hypersensitivity to DL and Loratadine.
  9. Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org).
  10. Presence of active cancer which requires chemotherapy or radiation therapy.
  11. Presence of acute urticaria / angioedema including laryngeal edema
  12. History or presence of alcohol abuse or drug addiction.
  13. Participation in any clinical trial within 4 weeks prior to enrolment.
  14. Intake of oral corticosteroids or other immunosuppressive therapy within 14 days prior to the beginning of the study.
  15. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study.
  16. Pregnancy or breast-feeding.
  17. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
desloratadine 20 mg
Drug: desloratadine
singel dose, oral, 20 mg
Drug: desloratadine
single dose, oral, 5 mg
Active Comparator: 2
desloratadine 20 mg
Drug: desloratadine
singel dose, oral, 20 mg
Drug: desloratadine
single dose, oral, 5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography.
Time Frame: 5 hours
5 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by volumetry and digital time lapse photography.
Time Frame: 5 hours
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Essex Pharma GmbH

Investigators

  • Principal Investigator: Marcus Maurer, MD, Allergie-Centrum-Charité

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 22, 2008

Study Record Updates

Last Update Posted (Estimate)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04805-V2.0
  • EudraCT number: 2006-003686-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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