NCT01056419

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 26, 2010

Status Verified

June 1, 2009

Enrollment Period

1.4 years

First QC Date

January 25, 2010

Last Update Submit

January 25, 2010

Conditions

Graves' Ophthalmopathy

Keywords

Graves' ophthalmopathyTotal thyroidectomyAnti-thyroid drug treatmentClinical activity score

Outcome Measures

Primary Outcomes (1)

  • Improvement in the proptosis and activity of Graves' ophthalmopathy

    12 months

Study Arms (2)

Total thyroidectomy

ACTIVE COMPARATOR
Procedure: Total Thyroidectomy

Anti-thyroid drug

ACTIVE COMPARATOR
Drug: Propylthiouracil

Interventions

Total ThyroidectomyPROCEDURE

Total thyroidectomy within 6 months after the appearance of the symptoms of ophthalmopathy

Total thyroidectomy
PropylthiouracilDRUG

150-600 mg in two-three divided doses

Anti-thyroid drug

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Medical School, Ibni Sina Hospital, Endocrinology and Metabolic Diseases Department

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Propylthiouracil

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Özgür Demir, M.D.

CONTACT

00903125082100dr.ozgurdemir@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2010

First Posted

January 26, 2010

Study Start

January 1, 2009

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

January 26, 2010

Record last verified: 2009-06

Locations

TU(1)