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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-ES-52030-352
  • IPS-SOM-2015-01 (Other Identifier: Spanish Drug Agency AEMPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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