An exploratory phase III, randomised, double blind, therapeutic single dose-related effect, parallel group study to assess and compare the effects of 5mg vs. 20mg Desloratadine on skin lesions in patients with chronic urticaria (CU). - AUD2OC

Phase 1

• Conditions: Chronic urticaria is characterized by the spontaneous development of wheal and flare type skin reactions.; MedDRA version: 9.1Level: LLTClassification code 10009159Term: Chronic urticaria

• Registration Number: EUCTR2006-003686-13-DE
• Lead Sponsor: Allergie-Centrum-Charite, Department of Dermatology, Charite - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-29
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 at the randomization visit.
3.History of beneficial effects of antihistaminic treatment.
4.Age between 18 and 75 years.
5.Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised. 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. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
6.Voluntarily signed written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 diarrhoea diseases, congenital malformations or surgical mutilations of 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified