EUCTR2016-004021-16-ES进行中(未招募)1 期
Response to oral lansoprazole in inorganic pyrophosphate levels in patients with Grönblad-Stranberg disease (Pseudoxanthoma Elasticum) - FIM-PXE-2016-01
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)0 个研究点目标入组 20 人开始时间: 2017年3月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 20
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.- Patients =18 years diagnosed of PXE according to the 2010 criteria of PLOMP et al (10) in follow-up at the Internal Medicine Consultation of the Virgen de la Victoria Hospital in Málaga and at the Internal Medicine Consultation of the Hospital Virgen de la Macarena de Sevilla and that meet at least two of the following criteria:
- •A. Retinal lesions peau d'orange type and / or angioid streaks.
- •B. Skin lesions consisting of papules or yellowish plaques on the lateral side of the neck and / or body flexures (axilary folds, elbows, knees) or alterations in the skin biopsy with fragmentation and / or conglomerates of and / or elastic fiber calcification.
- •C. A pathogenic mutation of the two alleles of the ABCC6 gene.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.- Refuse to give informed consent.
- •2.- Vegetarian diet or extreme diets.
- •3.- Pregnancy or intention during study period.
- •4.- Age <18 years.
- •5.- Known hypersensitivity to prazoles or proton pump inhibitors.
- •6.- Ingestion of medications that may interfere with PPIs (antifungal and atazanavir).
- •7.- Previous treatment with proton pump inhibitors, except for a 15 day wash period if the patient's clinical situation allows it
研究者
相似试验
Unknown
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Response to Oral Lansoprazole of Inorganic Pyrophosphate Levels in Patients With Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum)NCT04660461Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud20
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