DRUG
Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment
Status
Terminated
Phase
Phase 2
Enrollment
5
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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 contraction in patients with active thyroid-associated ophthalmopathy of moderate intensity.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Feb 8, 2006
Study start
Jan 2006
Primary completion
Apr 2007
Study completion
Apr 2007
Results posted
Not reported
Registry updated
Jun 2, 2020
Outcomes
What the study measures.
Primary outcomes
Extraocular muscle infiltration and edema exam by evaluating (at Day 0 and Weeks 4, 8 and 12): extraocular muscle size, proptosis and intraocular pressure (tonometry)
Eye inspection (at Day 0 and Weeks 4, 8 and 12): assessment of conjunctival injection presence, chemosis, cheratitis and eyelid edema; extrinsic muscle function evaluation and eyelid retraction
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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
Study locations
1 registered sites.
Spain. Showing up to 24 locations stored in the fast local snapshot.
Hospital General d'Alacant
Alicante, Spain
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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