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

August 1, 2019 updated by: Ipsen

Observational, Multicenter, Cross-sectional, Observational Study to Evaluate the Effectiveness in Routine Clinical Practice of Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) for the Treatment of Acromegaly: SOMACROL Study.

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.

Study Overview

Status

Completed

Conditions

Acromegaly

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Portugal
- - Lisboa, Portugal, 1649-035
    - Hospital de Santa Maria
  - Porto, Portugal, 4200-319
    - Centro Hospitalar Sao Joao
Spain
- - A Coruña, Spain, 15006
    - Complejo Hospitalario Univ. A Coruña
  - Alcalá de Henares, Spain, 28805
    - Hospital Univ. Príncipe de Asturias
  - Alicante, Spain, 03010
    - Hospital General Univ. de Alicante
  - Alzira, Spain, 46600
    - Hospital Univ. La Ribera
  - Badajoz, Spain, 06006
    - Hospital Infanta Cristina
  - Barakaldo, Spain, 48903
    - Hospital Cruces
  - Ciudad Real, Spain, 13005
    - Hospital Ciudad Real
  - Cádiz, Spain, 11009
    - Hospital Puerta del Mar
  - Córdoba, Spain, 14004
    - Hospital Reina Sofía
  - Getafe, Spain, 28905
    - Hospital de Getafe
  - Girona, Spain, 17007
    - Hospital Univ. Girona Dr. Josep Trueta
  - Hospitalet de Llobregat, Spain, 08907
    - Hospital Bellvitge
  - Jaén, Spain, 23005
    - Hospital de Jaen
  - León, Spain, 24001
    - Hospital Univ. León
  - Lleida, Spain, 25198
    - Hospital Arnau de Vilanova
  - Madrid, Spain, 28046
    - Hospital La Paz
  - Madrid, Spain, 28007
    - Hospital Gregorio Marañón
  - Madrid, Spain, 28006
    - Hospital La Princesa
  - Madrid, Spain, 28222
    - Hospital Puerta del Hierro
  - Madrid, Spain, 28046
    - Hospital Univv. La Paz
  - Málaga, Spain, 29010
    - Hospital Virgen de la Victoria
  - Málaga, Spain, 29009
    - Hospital Civil de Málaga
  - Oviedo, Spain, 33011
    - Hospital Univ. Central de Asturias
  - Palma, Spain, 07120
    - Hospital Univ. Son Espases
  - Sabadell, Spain, 08208
    - Corporacio Sanitaria Parc Tauli
  - San Sebastian de los Reyes, Spain, 28702
    - Hospital Infanta Sofía
  - Santiago de Compostela, Spain, 15706
    - Hospital Clínico Univ. Santiago
  - Sevilla, Spain, 41013
    - Hospital Virgen Del Rocio
  - Terrassa, Spain, 08221
    - Hospital Univ. Alava
  - Terrassa, Spain, 08221
    - Hospital Univ. Mutua de Terrassa
  - Teruel, Spain, 44002
    - Hospital Obispo Polanco
  - Toledo, Spain, 45005
    - Hospital Virgen de la Salud
  - Valencia, Spain, 46010
    - Hospital Clínico de Valencia
  - Valencia, Spain, 46026
    - Hospital Univ. La Fe
  - Valladolid, Spain, 47003
    - Hospital Clínico Univ. Valladolid
  - Zaragoza, Spain, 50009
    - Hospital Miguel Servet
- Tenerife
  - Santa Cruz, Tenerife, Spain, 38010
    - Hospital Univ. Nuestra Sra. Candelaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit. Time Frame: Day 1	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit. Time Frame: Day 1		Day 1
Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks. Time Frame: Day 1		Day 1
Percentage of subjects whose dosing regimen has been changed in the six months before the study. Time Frame: Day 1		Day 1
Preference for self-administered injections or administration in an outpatient clinic by a medical professional. Time Frame: Day 1		Day 1
Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals. Time Frame: Day 1	Total score and score per domain	Day 1
EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals. Time Frame: Day 1	Total score and score per domain	Day 1
Treatment Satisfaction Questionnaire for Medication-9 (TSMQ-9) in subjects treated with ATG 120 mg at extended dosing intervals after ≥ 5 months. Time Frame: Day 1	Total score and score per domain	Day 1
Variations between theoretical and real treatment compliance for non-medical reasons. Time Frame: Day 1		Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

June 16, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified