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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01056419
Other study ID # 08067
Secondary ID
Status Recruiting
Phase Phase 4
First received January 25, 2010
Last updated January 25, 2010
Start date January 2009
Est. completion date August 2010

Study information

Verified date June 2009
Source Ankara University
Contact Özgür Demir, M.D.
Phone 00903125082100
Email dr.ozgurdemir@gmail.com
Is FDA regulated No
Health authority Turkey: Ethics CommitteeTurkey: Ministry of Health
Study type Interventional

Clinical Trial Summary

The relationship between the method of the treatment of hyperthyroidism due to Graves' disease and the course of Graves' ophthalmopathy is debated. The investigators aimed to compare the results of total thyroidectomy done in 6 months following the appearance of the symptoms of ophthalmopathy and the antithyroid drug therapy in patients with moderate to severe Graves' ophthalmopathy.

The inclusion criteria: 1)Hyperthyroidism and moderate to severe Graves' ophthalmopathy within 6 months, 2)Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography, 3)Patients taking no treatment except local medications for Graves' ophthalmopathy, 4)Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater than or equal to 9 mm.

All patients will be treated with antithyroid drug until TSH levels of the patients are between 0.4-1. During this period all the patients will take pulse methyl prednisolone treatment of a total dose of 4.5 gr. After pulse steroid treatment the patients will be randomised to two groups: one group will be sent to surgery for total thyroidectomy, and their TSH levels will be kept between 0.4-1 with levothyroxine treatment; the other group will be followed under antithyroid drug treatment and their TSH levels will be kept between 0.4-1 also.

The smoking habits will be asked. Serum TSH, fT4 levels, Hertelmeter and eye lid opening measurements, clinical activity scores, diplopia will be evaluated monthly; TSH receptor antibody, anti-thyroid peroxidase and anti-thyroglobulin levels will be measured in 3 months intervals for a period of 12 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Hyperthyroidism and moderate to severe Graves' ophthalmopathy within 6 months,

- Thyroid volumes greater than or equal to 15 mL in thyroid ultrasonography,

- Patients taking no treatment except local medications for Graves' ophthalmopathy,

- Clinical activity score of 3/7 or more, proptosis greater than or equal to 21 mm in one eye or 2 mm difference between two eyes, presence of diplopia, the opening of the eye lid greater than or equal to 9 mm.

Exclusion Criteria:

- Patients taking treatment other than local medications for Graves' ophthalmopathy (eg: steroid treatment)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Total Thyroidectomy
Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy
Drug:
Propylthiouracil
150-600 mg in two-three divided doses

Locations

Country Name City State
Turkey Ankara University, Medical School, Ibni Sina Hospital, Endocrinology and Metabolic Diseases Department Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in the proptosis and activity of Graves' ophthalmopathy 12 months No
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Completed NCT00430547 - Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies N/A
Completed NCT03922321 - Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy (GO) Phase 2