Dose finding study (phase II) to investigate efficacy and tolerability of a 6 month oral treatment with three different strenghts of selenium (trade name: Cefasel) compared to placebo in patients with autoimmune thyroiditis (Hashimoto's disease, inflammation of the thyroid):double blind, random allocation to treatment groups

• Conditions: Autoimmune thyroiditis (Hashimoto-thyroiditis); MedDRA version: 14.0Level: LLTClassification code 10019167Term: Hashimoto's thyroiditisSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2007-001107-38-DE
• Lead Sponsor: Cefak KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-31
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

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