Treatment of Graves´ ophthalmopathy with diclofenak or simvastati

Conditions: Graves´ophthalmopathy
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2015-004334-99-SE

Lead Sponsor: Department of Endocrinology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 102

Inclusion Criteria

1.Age 18-70 years
2.Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu). Exophthalmos up to 24 mm with a disease duration of <18 months (as recorded by the patient)
3.a. Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD)
b. or 2 months treatment with ATD
c. or euthyroid 6 months after treatment with radioiodine
d. or euthyroid after total thyroidectomy.
Clinical and laboratory euthyroidism is defined as normal fT4, fT3 and TSH below the upper limit of the local reference interval (Malmö 3.7, Odense? Århus 4.3) and no clinical symtoms or signs of hyperthyroidism. L-thyroxine is used to achieve euthyroidism during the study period.

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 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Pregnancy or breast-feeding
2.Previous treatment for GO
3.Severe GO requiering corticosteroid treatment, retrobulbar irradiation, orbital or decompression surgery
4.Current or previous treatment with diclofenak (within 3 months for more than 7 consecutive days) or simvastatin or other statins (within 3 months)
5.Allergy (skin rash or systemic reactions) to NSAID, ASA or statins
6.Congestive heart failure
7.Renal insufficiency (glomerular filtration rate <60 ml/min)
8.ASAT or ALAT > 2.5 times the upper limit of the local laboratory
9.Alcoholism as judged by local criteria
10.Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs
11.Previous or current gastric ulcer
12.Inflammatory bowel disease diabetic retinopathy or nephropathy
13.Trauma within 10 Days