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Lanreotide (Somatuline Autogel) in Thyroid-Associated Ophthalmopathy Treatment

This study has been terminated.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00288522
First received: February 7, 2006
Last updated: April 17, 2007
Last verified: April 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Eye Diseases
Graves Ophthalmopathy
Thyroid Diseases
Autoimmune Diseases
Endocrine System Diseases
Exophthalmos
Eye Diseases, Hereditary
Goiter
Graves Disease
Hyperthyroidism
Immune System Diseases
Orbital Diseases
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014