EUCTR2007-001107-38-DE进行中（未招募）不适用
Dose finding study to investigate efficacy and tolerability of a 6 month oral treatment with selenium in patients with autoimmune thyroiditis:prospective, controlled parallel group study with Cefasel versus placebo- double blind, randomised clinical multicentre study of phase II with four treatment groups -Study title in German (see study protocol): Dosisfindungsstudie zur Untersuchung der Wirksamkeit und Verträglichkeit einer 6-monatigen oralen Selen-Behandlung bei autoimmuner Thyreoiditis: prospektiver, kontrollierter Parallelvergleich von Cefasel versus Placebo- doppelblinde, randomisierte, klinische Multizenterstudie der Phase II mit vier Behandlungsgruppen
Cefak KG0 个研究点目标入组 200 人开始时间: 2008年3月31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
- 200
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. Mature ambulant patient at the age of 18 - 80 years
- •2. Patients who have given their signed declaration of consent and data protection declaration
- •3. Thyroid peroxidase (TPO) antibody titre at least tenfold above the normal range or at least fivefold above the normal range and positive finding on sonograhy (diffuse reduced echogenicity of the tissue)
- •4. Basal TSH < 4.5 mIU/l and FT4 within normal ranges
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Previous and concomitant therapy not permitted
- •2. Basedow's disease
- •3. Further manifestations of pluriglandular insufficiency syndrome with the exception of vitiligo
- •4. Indication of thyroid functional autonomies
- •5. Manifest hypothyroidism, defined by basal TSH above normal range for the respective method and FT4 below normal range
- •6. Previous radioiodine therapy or operation on the thyroid
- •7. Suspicion to a malign tumour of the thyroid gland on sonography
- •8. Indication of malassimilation
- •9. Intolerance against any excipient of Cefasel 100 µg
- •10. Females in the childbearing years without appropriate contraception
- •11. Pergnancy (present or planned) or lactation
- •12. Present malign disease (current or within the past 5 years without recurrence)
- •13. Severe somatopahtic, neurological and/or psychiatric diseases
- •14. Patients who do not agree to the transmission of their pseudonymous data within the liability of documentation and notification
- •15. Participation in another clinical trial (parallel or within the past 6 months)
- •16. Participation in the same clinical trial
- •17. History of alcohol and/or drug of abuse
- •18. Patients who are unable to understand the nature, scope and possible impact of the study or considered to be non-compliant concerning drug intake or the study activities
- •19. Planned move or holidays during the course of the study so that not all study visits can be followed
- •20. Insufficient knowledge of language (German in written and spoken)
研究者
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