EUCTR2005-002582-37-DE进行中（未招募）不适用
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
Allergie-Centrum-Charité Universitätsmedizin Berlin0 个研究点目标入组 30 人开始时间: 2005年10月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
招募中
3 期
Effect of piperine supplement in patients with non alcoholic fatty liver diseaseIRCT20180802040678N2Tabriz University of Medical Sciences64
招募中
1 期
The efficacy of aprepitant for the prevention of postoperative nausea and vomiting after bariatric surgery.Postoperative nausea and vomitingCTIS2023-508849-40-00niversity Of Tartu260
招募中
3 期
Evaluation of the efficacy of Aprepitant in vomiting of children with cancerMalignant cancer.Agranulocytosis secondary to cancer chemotherapyD70.1IRCT20200204046377N1Shahid Beheshti University of Medical Sciences30
招募中
不适用
An examination of preventive effect of Carperitide for contrast induced nephropathy (CIN) in chronic kidney disease (CKD) patientsJPRN-UMIN000003892Departmrnt of cardiology, Nagoya university graduate school of medicine100
已完成
2 期
Combination therapy in vitiligoVitiligo.VitiligoIRCT2016061527802N2Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences30