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Treatment of Graves´Ophthalmopathy With Simvastatin (GO-DS)

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ClinicalTrials.gov Identifier: NCT03131726
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Lund University

Brief Summary:
In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy treated with simvastatin or no treatment.

Condition or disease Intervention/treatment Phase
Graves Ophthalmopathy Thyroid Associated Ophthalmopathy Thyroid Associated Orbitopathy Drug: Simvastatin 40mg Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Graves´Ophthalmopathy With Simvastatin (GO-DS)
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : January 26, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: Simvastatin
simvastatin 40 mg daily for 6 months
Drug: Simvastatin 40mg
see arm description
Other Name: ATC-code: C10AA01

No Intervention: No treatment
No treatment



Primary Outcome Measures :
  1. Change in Clinical activity score (CAS) after 6 months [ Time Frame: 6 months ]
    Change in 7-point clinical activity score (CAS) after 6 months treatment with simvastatin or no treatment

  2. Number of patients with progression to severe GO during 6 months [ Time Frame: 6 months ]
    Number of patients with progression to severe GO in each group (simvastatin, no treatment) during 6 months treatment


Secondary Outcome Measures :
  1. Change in Modified Clinical activity score [ Time Frame: 3 and 6 months ]
    Change in Modified clinical activity score after 3 and 6 months treatment with simvastatin or no treatment

  2. Optical coherence tomography [ Time Frame: 3 and 6 months ]
    Evaluation of conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with simvastatin or no treatment

  3. Quality of life with SF36 [ Time Frame: 6 months ]
    Quality of life after 6 months treatment with simvastatin or no treatment assessed with the SF36 questionnaire

  4. Quality of life with ThyrPro [ Time Frame: 6 months ]
    Quality of life after 6 months treatment with simvastatin or no treatment assessed with the ThyPro questionnaire

  5. Quality of life with GO-QoL [ Time Frame: 6 months ]
    Quality of life after 6 months treatment with simvastatin or no treatment assessed with the GO-QoL questionnaire

  6. TRAb [ Time Frame: 3 and 6 months ]
    TRAb after 3 and 6 months treatment with simvastatin or no treatment

  7. TPO-Ab [ Time Frame: 3 and 6 months ]
    TPOAb after 3 and 6 months treatment with simvastatin or no treatment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <18 months (as recorded by the patient)
  3. Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD), or 2 months treatment with ATD, or euthyroid 6 months after treatment with radioiodine, or euthyroid after total thyroidectomy. Clinical and laboratory euthyroidism is defined as normal fT4, fT3 and TSH below the upper limit of the local reference interval and no clinical symptoms or signs of hyperthyroidism. L-thyroxine is used to achieve euthyroidism during the study period.

Exclusion Criteria:

  1. Pregnancy or breast-feeding
  2. Previous treatment of Graves´ ophthalmopathy
  3. Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery
  4. Current or previous treatment with simvastatin or other statins (within 3 months)
  5. Allergy (skin rash or systemic reactions) to 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 diabetic retinopathy or nephropathy
  13. Trauma within 10 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131726


Contacts
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Contact: Tereza Planck, MD, PhD +46-733873399 tereza.planck@med.lu.se
Contact: Mikael Lantz, MD, PhD +46-708202315 mikael.lantz@med.lu.se

Locations
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Sweden
Dpt. of Endocrinology, SUS Malmö Recruiting
Malmö, Sweden
Contact: Tereza Planck, MD, PhD       tereza.planck@med.lu.se   
Contact: Mikael Lantz, MD, PhD         
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Tereza Planck, MD, PhD Lund University and Skåne University Hospital

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03131726     History of Changes
Other Study ID Numbers: Tereza Planck
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lund University:
simvastatin
diclofenac
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Thyroid Diseases
Eye Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Autoimmune Diseases
Immune System Diseases
Exophthalmos
Goiter
Hyperthyroidism
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors