Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

NCT ID: NCT02698384

Last Updated: 2018-12-21

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

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.

Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 18 years or more, suffering from acromegaly
* Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA)
* Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects)
* In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy

Exclusion Criteria

* Subject previously/currently treated with Lanreotide 120mg
* History of radiotherapy for acromegaly
* Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression
* Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists
* Active neoplastic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Hoptial Nord

Amiens, , France

Site Status

Hopital jean Minjoz

Besançon, , France

Site Status

Hopital Neuro-Cardiologique, Fédération d'Endocrinologie

Bron, , France

Site Status

Hopital Albert Michallon

La Tronche, , France

Site Status

Hopital De La Conception

Marseille, , France

Site Status

Hopital Haut Leveque

Pessac, , France

Site Status

Hopital Robert Debre

Reims, , France

Site Status

Hopital Nord

Saint-Etienne, , France

Site Status

Hopital De Hautepierre

Strasbourg, , France

Site Status

Hopital Larrey

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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A-54-52030-315

Identifier Type: -

Identifier Source: org_study_id