Clincosm LogoSign in Get a demo

AECUDATT: Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria

Sponsor
Marcus Maurer (Other)
Overall Status
Completed
CT.gov ID
NCT01444196
Collaborator
Johannes Gutenberg University Mainz (Other)
30
Enrollment
1
Location
2
Arms
9
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

A total of 30 patients (male and female) with ACU will be included in this study

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Multi-center, Double Blind, Dose Escalating Study to Compare the Effects of 5 mg, 10mg and 20mg of Desloratadine in Patients With Acquired Cold Urticaria (ACU)
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
May 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Other: Desloratadine dose

Study group: 5 mg Desloratadine during the whole study Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4.

Drug: Desloratadine
Every day,per mouth,in the evening, for 14 +- 2 days.
Other Names:
  • No arm names.

    		•
    Other: Dose of Desloratadine

    Study group: 5 mg Desloratadine during the whole study Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4.

    Drug: Desloratadine
    Every day,per mouth,in the evening, for 14 +- 2 days.
    Other Names:
  • No arm names.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs [6 weeks]

    Secondary Outcome Measures

    1. Presence of wheal(s) at 4°C Intensity of pruritus and burning Number and duration of angioedemas QoL as assessed by DLQI Severity of ACU (by ACUSI) [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Informed consent signed and dated

    • Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner

    • Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.

    • Age between 18 and 75 years

    Exclusion Criteria:

    • Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).

    • The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria

    • The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)

    • History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia

    • History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy

    • Evidence of severe renal dysfunction

    • Evidence of significant hepatic disease (liver enzymes twice the upper reference value)

    • History of adverse reactions to DL

    • Presence of active cancer which requires chemotherapy or radiation therapy

    • Presence of alcohol abuse or drug addiction

    • Intake of oral corticosteroids within 14 days prior to screening visit

    • Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit

    • Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.

    • Pregnancy or breast-feeding

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Dermatology, Venerology and Allergology Berlin Germany 10117

    Sponsors and Collaborators

    • Marcus Maurer
    • Johannes Gutenberg University Mainz

    Investigators

    • Principal Investigator: Marcus Maurer, Prof., Charite, University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Marcus Maurer, Head of Research Dept. of Dermatology, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT01444196
    Other Study ID Numbers:
    • 2008-005746-22
    • 2008-005746-22
    First Posted:
    Sep 30, 2011
    Last Update Posted:
    Oct 3, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Marcus Maurer, Head of Research Dept. of Dermatology, Charite University, Berlin, Germany
    ACU
    acquired cold urticaria
    Additional relevant MeSH terms:
    Urticaria
    Desloratadine

    Study Results

    No Results Posted as of Oct 3, 2011