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

Primary Purpose

Urticaria

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Desloratadine

About this trial

This is an interventional treatment trial for Urticaria focused on measuring ACU, acquired cold urticaria

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Dermatology, Venerology and Allergology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Desloratadine dose

Dose of Desloratadine

Arm Description

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.

Outcomes

Primary Outcome Measures

CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01444196

First Posted

September 29, 2011

Last Updated

September 30, 2011

Sponsor

Marcus Maurer

Collaborators

Johannes Gutenberg University Mainz

1. Study Identification

Unique Protocol Identification Number

NCT01444196

Brief Title

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

Acronym

AECUDATT

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 Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Marcus Maurer

Collaborators

Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee

Yes

5. 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urticaria

Keywords

ACU, acquired cold urticaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Desloratadine dose

Arm Type

Other

Arm Description

Arm Title

Dose of Desloratadine

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

Desloratadine

Other Intervention Name(s)

No arm names.

Intervention Description

Every day,per mouth,in the evening, for 14 +- 2 days.

Primary Outcome Measure Information:

Title

CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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)

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcus Maurer, Prof.

Organizational Affiliation

Charite, University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology, Venerology and Allergology

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://urtikaria.net

Description

Kälteurtikaria

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

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