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Treatment of Graves´ ophthalmopathy with diclofenak or simvastatin
EU CTIS ID: 2024-517833-42-00
What this study is testing
To evaluate Graves´ ophthalmopathy (GO) activity and progress to severe GO in patients with mild to moderate GO who are treated with diclofenac, simvastatin or do not receive additional treatment.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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. Graves´ disease with clinical and laboratory euthyroidism • after stopping treatment with anti-thyroid drugs (ATD), or • after at least 2 months treatment with ATD, or • at least 6 months after treatment with radioiodine, or • after total thyroidectomy.
You likely can't join if
- 1. Pregnancy or breast-feeding 2. Previous treatment of Graves´ ophthalmopathy 3. Severe Graves´ ophthalmopathy requiering corticosteroid treatment, retrobulbar irradiation, or orbital decompression surgery 4. Current or previous treatment with diclofenak (for more than 7 consecutive days during the previous 3 months), simvastatin or other statins (during the last 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 13. Diabetic retinopathy or nephropathy 14. Trauma during the last 10 days
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.