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Adjuvant Treatment of Graves? Ophthalmopathy With NSAID (aGO Study)

This study is currently Recruiting

October 2011 By Region Skane

First Recieved on October 19, 2011

Last Updated on October 21, 2011

Sponsor: Mikael Lantz
Collaborators:
Information provided by: Region Skane
Identifier: NCT01458600

Purpose

AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves? disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves? disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves? disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves?disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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 Exclusion Criteria: 1. Pregnancy or breastfeeding, women in childbearing age should use non- barrier contraceptives 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. Alcoholism 9. Coagulopathy including warfarin treatment 10. Thrombocytopenia 11. Previous or active gastric ulcera 12. Inflammatory bowel disease

Investigators

  • Investigator: Mikael Lantz, MD - Study Director - Department of Endocrinology, Skane University Hospital, Malm?, Sweden
  • Investigator: Jan Calissendorff, MD - Principal Investigator - Department of Endocrinology, Karolinska Hospital, Stockholm, Sweden
  • Investigator: Ove T?rring, MD - Principal Investigator - Department of Internal Medicine, section of Endocrinology, Sodersjukhuset, Stockholm

Locations

  • Departmenty of Endocrinology, Skane University Hospital

    Malm?, Sweden

  • Department of Endocrinology, Karolinska Hospital

    Stockholm, Sweden

  • Department of Internal Medicine, section of Endocrinology, Sodersjukhuset

    Stockholm, Sweden

Conditions related to this trial:

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