Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00430547




Registration number
NCT00430547
Ethics application status
Date submitted
1/02/2007
Date registered
2/02/2007
Date last updated
2/02/2007

Titles & IDs
Public title
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
Scientific title
Thyroid-Associated Ophthalmopathy Subtypes and Orbital Antibodies
Secondary ID [1] 0 0
03/53
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graves' Ophthalmopathy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Carbimazole, radio-active iodine (I131)

Treatment: Drugs: Carbimazole, radio-active iodine (I131)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Onset or progression of ophthalmopathy following radio-active iodine therapy
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Graves' disease diagnosed in the last 3 months, regardless of the presence of
ophthalmopathy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pre-existing eye disease: e.g. orbital surgery, orbital irradiation or significant
loss of vision

- Age < 18 years

- Inability to consent to participation in the study

- Pregnancy

- History of radio-active iodine therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Barwon Health - The Geelong Hospital - Geelong
Recruitment postcode(s) [1] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Other
Name
Barwon Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether radioactive iodine, as compared to
anti-thyroid medications, is a risk factor for the development or progression of
thyroid-associated ophthalmopathy in patients with hyperthyroidism due to Graves' disease.
The other aim of this study is to determine the incidence of the various ophthalmopathy
subtypes and the utility of orbital antibodies in the diagnosis, classification and
monitoring of patients with thyroid-associated ophthalmopathy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00430547
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jack R Wall, BMBS, FRACP, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00430547