Current partner codePEPTIDESDE
NCT00288522·Phase 2·INTERVENTIONAL

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.

DRUG

Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days

Timeline

From registration to results.

  1. First posted

    Feb 8, 2006

  2. Study start

    Jan 2006

  3. Primary completion

    Apr 2007

  4. Study completion

    Apr 2007

  5. Results posted

    Not reported

  6. 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.

Primary links

Continue at the source.

Related trials

More studies on Lanreotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.