Treatment of Graves´ ophthalmopathy with diclofenak or simvastatin

Treatment of Graves´ ophthalmopathy with diclofenak or simvastatin - GO-DS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004334-99-SE

Enrollment

102

Registered

2015-11-30

Start date

2016-02-01

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves´ophthalmopathy

Interventions

Trade Name: Diclofenac T Ratiopharm Product Name: Diclofenac T Ratiopharm Pharmaceutical Form: Tablet INN or Proposed INN: Diclofenac Other descriptive name: DICLOFENAC Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine Clinical activity score (CAS) after 6 months treatment with or without diclofenak or simvastatin and progression to severe GO;Secondary Objective: 1.To evaluate whether modified CAS is better than CAS in discriminating changes in activity score? 2.To evaluate conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with diclofenak or simvastatin 3.To evaluate quality of life after 6 months treatment with diclofenak or simvastatin 4.To evaluation changes in TRAb and TPOAb after 3 and 6 months treatment with diclofenak or simvastatin? 5.To evaluation novel markers of active ophthalmopathy identified with microarray, metabolomics and bioassays after 3 and 6 months treatment with diclofenak or simvastatin? ;Primary end point(s): 1.Clinical activity score (CAS) after 6 months treatment with or without diclofenak or simvastatin and progression to severe GO;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Main Objective: To determine Clinical activity score (CAS) after 6 months treatment with or without diclofenak or simvastatin and progression to severe GO;Secondary Objective: 1.To evaluate whether modified CAS is better than CAS in discriminating changes in activity score? 2.To evaluate conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with diclofenak or simvastatin 3.To evaluate quality of life after 6 months treatment with diclofenak or simvastatin 4.To evaluation changes in TRAb and TPOAb after 3 and 6 months treatment with diclofenak or simvastatin? 5.To evaluation novel markers of active ophthalmopathy identified with microarray, metabolomics and bioassays after 3 and 6 months treatment with diclofenak or simvastatin? ;Primary end point(s): 1.Clinical activity score (CAS) after 6 months treatment with or without diclofenak or simvastatin and progression to severe GO;Timepoint(s) of evaluation of this end point: 6 months

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Secondary

Measure	Time frame
Secondary end point(s): 1. Evaluation of whether modified CAS is better than CAS in discriminating changes in activity score? 2. Evaluation of conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with diclofenak or simvastatin 3. Evaluation of quality of life after 6 months treatment with diclofenak or simvastatin 4. Evaluation of changes in TRAb and TPOAb after 3 and 6 months treatment with diclofenak or simvastatin? 5. Evaluation of novel markers of active ophthalmopathy identified with microarray, metabolomics and bioassays after 3 and 6 months treatment with diclofenak or simvastatin? ;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

Secondary end point(s): 1. Evaluation of whether modified CAS is better than CAS in discriminating changes in activity score? 2. Evaluation of conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with diclofenak or simvastatin 3. Evaluation of quality of life after 6 months treatment with diclofenak or simvastatin 4. Evaluation of changes in TRAb and TPOAb after 3 and 6 months treatment with diclofenak or simvastatin? 5. Evaluation of novel markers of active ophthalmopathy identified with microarray, metabolomics and bioassays after 3 and 6 months treatment with diclofenak or simvastatin? ;Timepoint(s) of evaluation of this end point: 6 months

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Countries

Sweden

Contacts

Public ContactMikael Lantz

Department of Endocrinology

Mikael.Lantz@med.lu.se046403310002286

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026