Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects

NCT ID: NCT02807233

Last Updated: 2019-08-05

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

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-09-30

Brief Summary

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The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (\>4 weeks) in subjects with acromegaly in daily clinical practice.

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

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Men or women aged ≥ 18 years
* Diagnosed with acromegaly
* Receiving treatment with ATG 120 mg at extended dosing intervals (\> 4 weeks) for at least six months before the study visit.
* Assay data (blood GH and IGF-1 levels) from immediately before the study visit (performed at least six months after starting the treatment) is available.
* Able to sign the informed consent form for study participation.

Exclusion Criteria

* Received radiation therapy treatment in the last six months.
* Active participation in another clinical study.
* Physical or mental disorders that, in the investigator's opinion, could affect their ability to sign the informed consent form.
* Pregnancy or breastfeeding for female patients.
* No data in their medical records on the treatment start date for ATG 120 mg at extended dosing intervals or on changes to the schedule of administration over the last six months.
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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Hospital de Santa Maria

Lisbon, , Portugal

Site Status

Centro Hospitalar Sao Jöao

Porto, , Portugal

Site Status

Hospital Univ. Nuestra Sra. Candelaria

Santa Cruz, Tenerife, Spain

Site Status

Complejo Hospitalario Univ. A Coruña

A Coruña, , Spain

Site Status

Hospital Univ. Príncipe de Asturias

Alcalá de Henares, , Spain

Site Status

Hospital General Univ. de Alicante

Alicante, , Spain

Site Status

Hospital Univ. La Ribera

Alzira, , Spain

Site Status

Hospital Infanta Cristina

Badajoz, , Spain

Site Status

Hospital Cruces

Barakaldo, , Spain

Site Status

Hospital Puerta del Mar

Cadiz, , Spain

Site Status

Hospital Ciudad Real

Ciudad Real, , Spain

Site Status

Hospital Reina Sofía

Córdoba, , Spain

Site Status

Hospital de Getafe

Getafe, , Spain

Site Status

Hospital Univ. Girona Dr. Josep Trueta

Girona, , Spain

Site Status

Hospital de Jaén

Jaén, , Spain

Site Status

Hospital Bellvitge

L'Hospitalet de Llobregat, , Spain

Site Status

Hospital Univ. León

León, , Spain

Site Status

Hospital Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital La Princesa

Madrid, , Spain

Site Status

Hospital Gregorio Marañón

Madrid, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Hospital Univv. La Paz

Madrid, , Spain

Site Status

Hospital Puerta del Hierro

Madrid, , Spain

Site Status

Hospital Civil de Málaga

Málaga, , Spain

Site Status

Hospital Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Univ. Central de Asturias

Oviedo, , Spain

Site Status

Hospital Univ. Son Espases

Palma, , Spain

Site Status

Corporacio Sanitaria Parc Tauli

Sabadell, , Spain

Site Status

Hospital Infanta Sofía

San Sebastián de los Reyes, , Spain

Site Status

Hospital Clínico Univ. Santiago

Santiago de Compostela, , Spain

Site Status

Hospital Virgen del Rocío

Seville, , Spain

Site Status

Hospital Univ. Alava

Terrassa, , Spain

Site Status

Hospital Univ. Mutua de Terrassa

Terrassa, , Spain

Site Status

Hospital Obispo Polanco

Teruel, , Spain

Site Status

Hospital Virgen de la Salud

Toledo, , Spain

Site Status

Hospital Clínico de Valencia

Valencia, , Spain

Site Status

Hospital Univ. La Fe

Valencia, , Spain

Site Status

Hospital Clínico Univ. Valladolid

Valladolid, , Spain

Site Status

Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Portugal Spain

Other Identifiers

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IPS-SOM-2015-01

Identifier Type: OTHER

Identifier Source: secondary_id

A-ES-52030-352

Identifier Type: -

Identifier Source: org_study_id

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