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Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

Primary Purpose

Thyroid-Associated Ophthalmopathy

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid-Associated Ophthalmopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General d'Alacant

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
February 7, 2006
Last Updated
June 1, 2020
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00288522
Brief Title
Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy 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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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 contraction in patients with active thyroid-associated ophthalmopathy of moderate intensity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid-Associated Ophthalmopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lanreotide (Autogel formulation). Duration of treatment - 3 injections, 1 every 28 days
Primary Outcome Measure Information:
Title
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)
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Hospital General d'Alacant
City
Alicante
ZIP/Postal Code
03012
Country
Spain

12. IPD Sharing Statement

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Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

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