Status:
TERMINATED
Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment
Lead Sponsor:
Ipsen
Conditions:
Thyroid-Associated Ophthalmopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of 3 doses of Somatuline Autogel 60mg to control the muscle infiltration and edema, eyelid retraction and extraocular muscular con...
Eligibility Criteria
Inclusion
- Patients with autoimmune thyroid disease and whose centre's medical records confirm the presence of euthyroidism for at least two months before being included into the study
- Thyroid-associated ophthalmopathy diagnosed a minimum of six months before his/her participation in the study, well documented in the centre's medical records and based on the moderate intensity of thyroid-associated ophthalmopathy in the worst eye
- Patients whose ophthalmopathy activity has been demonstrated by a positive octreoscan
Exclusion
- The patient presents compressive optical neuropathy signs which require immediate surgical treatment or suffers from serious intensity thyroid ophthalmopathy
- The patient has been treated with radio-iodine for his/her thyroid disturbance in the past 6 months
- The patient's thyroid-associated ophthalmopathy has been treated previously (except for drops and local measures) or is planned to be treated with radio-iodine or thyroidectomy for his/her autoimmune thyroid disease during the study or suffers from myopia, glaucoma or any other eye disease which could modify the ophthalmological progress
- The patient is a smoker of more than 5 cigarettes per day
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00288522
Start Date
January 1 2006
End Date
April 1 2007
Last Update
June 2 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital General d'Alacant
Alicante, Spain, 03012