Graves´ophthalmopathy
Conditions
Interventions
Trade Name: Diclofenac T ratiopharm
Product Name: Diclofenac T ratiopharm
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Sponsors
Department of Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Graves thyrotoxicosis ( with clinical symptoms) 2. Age 18 – 75 year 3. TSH = 0.2 or =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnancy or intention of pregnancy within 1 year 2. Previous treatment of thyroid disease 3. Thyrostatics before radioiodine treatment 4. Hypersensitivity to NSAID or ASA 5. Congestive heartfailure 6. Impaired renal function defined as p-creatinine > 100 mmol/L 7. ASAT or ALAT > 2.5 times the upper limit 8. Alcholism 9. Coagulopathy including warfarin treatment 10. Thrombocytopenia 11. Previous or active gastric ulcera 12. Inflammatory bowel disease 13. Diabetes retinopathy or nephropathy 14. Trauma < 10 days 15. Corticosteroid treated ophthalmopathy at diagnosis of thyrotoxicosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to find out if diclofenac can prevent development of ophthalmopathy.;Secondary Objective: 1. Determine the activity at diagnosis of ophthalmopathy 2. Determine the time from thyrotoxicosis to ophthalmopathy 3. Determine the frequency of patients with corticosteroid requireing ophthalmopathy ;Primary end point(s): Primary endpoint: The frequency of ophthalmopathy after 24 months as judged by the following clinical signs:. Optic nerve dysfunction 0. No 1. Yes Eye-lid edema 0. No 1. Yes Chemosis 0. No 1. Yes Conjunctival injection 0. No 1. Yes Exophthalmos 0. No 1. Yes Hertel - base right left Eye muscle dysfunction 0. No 1. Yes Corneal ulcers 0. No 1. Yes Sum: Ophthalmopathy is present if the patient has one sign or more | — |
Countries
Sweden
Outcome results
None listed