Characterization of protective effects of a piperidine derivative (DPMP, 4-diphenylmethoxy-1 [3-(4-ter-butylbenzoyl)-propyl] piperidine) on cognitive impairment in urticaria patients - cognitive impairment in urticaria patients

• Conditions: rticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus. In Europe alone, more than 5 million patients are thought to suffer from persisting urticaria symptoms which either occur spontaneously or as a result of environmental physical stimuli. Urticaria is known to severely impair the quality of life of affected patients. Thus, the majority of patients requires high-dosed antihistaminic drugs.

• Registration Number: EUCTR2005-002582-37-DE
• Lead Sponsor: Allergie-Centrum-Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1.Outpatients with at least one of the following forms of physical urticaria for more than 6 weeks: 1) cold urticaria, 2) factitious dermographism. Urticarial symptoms must comprise wheal and itch.
2.History of beneficial effects of antihistaminic treatment.
3.History suggests association of performance impairment with increased disease activity.
4.Age between 18 and 70 years.
5.Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised.
6.Patients must be able and willing to assess and record symptom scores and to perform psychometric tests.
7.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 physical urticaria.
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.History of adverse reactions to DPMP.
8.Presence of QT changes
9.Intake of medicaments that could cause QT changes
10.Presence of active cancer which requires chemotherapy or radiation therapy.
11.Presence of acute urticaria.
12.History or presence of alcohol abuse or drug addiction.
13.Participation in any clinical trial within 4 weeks prior to enrolment.
14.Itch of other origin.
15.Intake of antihistamines or leukotriene modifiers within 7 days prior to the beginning of the study
16.Intake of oral corticosteroids within 14 days prior to the beginning of the study
17.Use of depot corticosteroids or chronic inhaled or systemic corticosteroids within 21 days before beginning of the study
18.Intake of drugs affecting psychomotoric functions or alertness (e.g. antidepressants, anxiolytics, benzodiazepines).
19.Intake of CYP3A4-inhibitors
20.Pregnancy or breast-feeding

Study & Design

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