Adjuvant treatment of Graves´ ophthalmopathy with NSAID (aGO study) - aGO study

Conditions: Graves´ophthalmopathy

Registration Number: EUCTR2005-000832-26-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: 300

Inclusion Criteria

1. Graves thyrotoxicosis ( with clinical symptoms)
2. Age 18 – 75 year
3. TSH = 0.2 or < 0.2 and increased fT4 and/or fT3
4. Signed informed consent

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>2. Determine the time from thyrotoxicosis to ophthalmopathy<br><br>3. Determine the frequency of patients with corticosteroid requireing ophthalmopathy<br><br><br>;Primary end point(s): Primary endpoint:<br><br>The frequency of ophthalmopathy after 24 months as judged by the following clinical signs:.<br>Optic nerve dysfunction0. No 1. Yes<br>Eye-lid edema 0. No 1. Yes<br>Chemosis 0. No 1. Yes<br>Conjunctival injection0. No 1. Yes<br>Exophthalmos 0. No 1. Yes <br> Hertel - base right left<br>Eye muscle dysfunction0. No 1. Yes<br>Corneal ulcers 0. No 1. Yes<br> Sum:<br>Ophthalmopathy is present if the patient has one sign or more<br>

Secondary Outcome Measures