Lanreotide (Somatuline Autogel) in Thyroid-associated Ophthalmopathy Treatment

NCT ID: NCT00288522

Last Updated: 2020-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid-Associated Ophthalmopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Hospital General d'Alacant

Alicante, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2004-003937-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A-92-52030-164

Identifier Type: -

Identifier Source: org_study_id

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