AcromegalySOMACROLNCT02807233
Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects
An observational study of Acromegaly, run by Ipsen at 39 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 115 participants
- Where
- 39 sitesin 2 countries
- Study dates
- Jul 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
Spain37 sites
Complejo Hospitalario Univ. A Coruña
A Coruña, 15006
Hospital Univ. Príncipe de Asturias
Alcalá de Henares, 28805
Hospital General Univ. de Alicante
Alicante, 03010
Hospital Univ. La Ribera
Alzira, 46600
Hospital Infanta Cristina
Badajoz, 06006
Hospital Cruces
Barakaldo, 48903
Hospital Puerta del Mar
Cadiz, 11009
Hospital Ciudad Real
Ciudad Real, 13005
Hospital Reina Sofía
Córdoba, 14004
Hospital de Getafe
Getafe, 28905
Hospital Univ. Girona Dr. Josep Trueta
Girona, 17007
Hospital de Jaén
Jaén, 23005
Hospital Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital Univ. León
León, 24001
Hospital Arnau de Vilanova
Lleida, 25198
Hospital La Princesa
Madrid, 28006
Hospital Gregorio Marañón
Madrid, 28007
Hospital La Paz
Madrid, 28046
Hospital Univv. La Paz
Madrid, 28046
Hospital Puerta del Hierro
Madrid, 28222
Hospital Civil de Málaga
Málaga, 29009
Hospital Virgen de la Victoria
Málaga, 29010
Hospital Univ. Central de Asturias
Oviedo, 33011
Hospital Univ. Son Espases
Palma, 07120
Corporacio Sanitaria Parc Tauli
Sabadell, 08208
Hospital Infanta Sofía
San Sebastián de los Reyes, 28702
Hospital Univ. Nuestra Sra. Candelaria
Santa Cruz, Tenerife, 38010
Hospital Clínico Univ. Santiago
Santiago de Compostela, 15706
Hospital Virgen del Rocío
Seville, 41013
Hospital Univ. Alava
Terrassa, 08221
Hospital Univ. Mutua de Terrassa
Terrassa, 08221
Hospital Obispo Polanco
Teruel, 44002
Hospital Virgen de la Salud
Toledo, 45005
Hospital Clínico de Valencia
Valencia, 46010
Hospital Univ. La Fe
Valencia, 46026
Hospital Clínico Univ. Valladolid
Valladolid, 47003
Hospital Miguel Servet
Zaragoza, 50009
Portugal2 sites
Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar Sao Jöao
Porto, 4200-319
About this study
Official title: 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.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.
Measured: Day 1
Secondary outcomes (8)
Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.
Measured: 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.
Measured: Day 1
Percentage of subjects whose dosing regimen has been changed in the six months before the study.
Measured: Day 1
Preference for self-administered injections or administration in an outpatient clinic by a medical professional.
Measured: Day 1
Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.
Total score and score per domain
Measured: Day 1
EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.
Total score and score per domain
Measured: Day 1
Treatment Satisfaction Questionnaire for Medication-9 (TSMQ-9) in subjects treated with ATG 120 mg at extended dosing intervals after ≥ 5 months.
Total score and score per domain
Measured: Day 1
Variations between theoretical and real treatment compliance for non-medical reasons.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807233
- Sponsor's protocol ID
- A-ES-52030-352
- Other IDs
- IPS-SOM-2015-01
- Acronym
- SOMACROL
- Status last verified
- Aug 2019
- First submitted
- 27 May 2016
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02807233
- Acronym / sponsor ID
- SOMACROL / A-ES-52030-352
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
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
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
Percentage of subjects whose dosing regimen has been changed in the six months before the study.
Time frame: Day 1
Preference for self-administered injections or administration in an outpatient clinic by a medical professional.
Time frame: 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
EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.
Time frame: 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
Variations between theoretical and real treatment compliance for non-medical reasons.
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Ipsen at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.