EUCTR2007-001107-38-DE
Active, not recruiting
Not Applicable
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 sites200 target enrollmentMarch 31, 2008
DrugsCefasel 100 µg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cefak KG
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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