Lanreotide (Somatuline Autogel) in Thyroid-Associated Ophthalmopathy Treatment - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00288522

Purpose

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.

Condition	Intervention	Phase
Thyroid-Associated Ophthalmopathy	Drug: Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days	Phase II

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome

MedlinePlus related topics: Edema

Drug Information available for: Lanreotide acetate Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Single Centre, Randomized, Double-Blind, Parallel and Placebo Controlled, Pilot Study to Evaluate the Efficacy and Safety of Somatuline Autogel 60mg in Patients With Active Thyroid-Associated Ophthalmopathy of Moderate Intensity.

Further study details as provided by Ipsen:

Primary Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288522

Locations

Spain
Hospital General d'Alacant
Alicante, Spain, 03012

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Eva Pineda, MD

Ipsen

More Information

No publications provided

Study ID Numbers:	A-92-52030-164
Study First Received:	February 7, 2006
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00288522 History of Changes
Health Authority:	Spain: Drug and Sanitary Products Spanish Agency

Study placed in the following topic categories:

Goiter
Autoimmune Diseases
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Angiopeptin
Endocrine System Diseases
Cardiovascular Agents

Lanreotide
Graves' Disease
Eye Diseases, Hereditary
Orbital Diseases
Endocrinopathy
Thyroid Diseases
Hyperthyroidism

Additional relevant MeSH terms:

Goiter
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Graves Ophthalmopathy
Eye Diseases
Graves Disease
Angiopeptin
Endocrine System Diseases

Cardiovascular Agents
Pharmacologic Actions
Exophthalmos
Lanreotide
Therapeutic Uses
Eye Diseases, Hereditary
Orbital Diseases
Thyroid Diseases
Hyperthyroidism

ClinicalTrials.gov processed this record on May 07, 2009