EUCTR2011-006275-20-DE进行中（未招募）不适用
A phase II exploratory study evaluating the efficacy of topical cromoglicate solution(20mg/ml) compared to topical solution vehicle in the treatment of mastocytosis - Cromoglicate in Mastocytosis
EO Pharma A/S0 个研究点开始时间: 2012年6月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Signed informed consent has been obtained
- •2.Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocy-tosis with skin involvement and a positive Darier’s Sign
- •3.Age between 18 and 70 years
- •4.Either sex
- •5.Any race or ethnicity
- •6.Attending hospital outpatient clinic or the private practice of a dermatologist
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.The presence of autoimmune and infectious disease including aggressive systemic mastocytosis
- •2.Medical history or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or is-chemia
- •3.Medical history or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy, hyper/hypokalemia
- •4.Evidence of severe renal dysfunction (creatinine > 1,5 times upper reference value)
- •5.Evidence of significant hepatic disease (liver enzymes > 2 times upper reference value)
- •6.Presence of active cancer which requires chemothera-py or radiation therapy
- •7.Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG
- •8.Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
- •9.Intake of oral corticosteroids within 14 days prior to randomisation
- •10.Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to randomisation
- •11.Radiation therapy of target areas including UV therapy within 4 weeks prior to randomisation
- •12.Confounding other dermatological diseases or conditions that can affect the symptoms of the target areas
- •13.Known or suspected hypersensitivity to component(s) of investigational products.
- •14.Current participation in any other interventional clinical trial.
- •15.Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation
- •16.Previously randomised in this clinical trial
- •17.In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
- •18.Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding.
- •19.Females of child-bearing potential with positive pregnancy test at visit 1.
- •20.Subjects (or their partner) not using an adequate method of contraception (according to national re-quirements, as applicable)
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