Clinical trial NCT02807233: Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.
timeFrame: Day 1
measure: Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks.
timeFrame: Day 1
measure: Percentage of subjects whose dosing regimen has been changed in the six months before the study.
timeFrame: Day 1
measure: Preference for self-administered injections or administration in an outpatient clinic by a medical professional.
timeFrame: Day 1
measure: Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.
timeFrame: Day 1
measure: EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals.
timeFrame: Day 1
measure: Treatment Satisfaction Questionnaire for Medication-9 (TSMQ-9) in subjects treated with ATG 120 mg at extended dosing intervals after ≥ 5 months.
timeFrame: Day 1
measure: Variations between theoretical and real treatment compliance for non-medical reasons.
timeFrame: Day 1
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar Sao Jöao
city: Santa Cruz
country: Spain
facility: Hospital Univ. Nuestra Sra. Candelaria
state: Tenerife
city: A Coruña
country: Spain
facility: Complejo Hospitalario Univ. A Coruña
city: Alcalá de Henares
country: Spain
facility: Hospital Univ. Príncipe de Asturias
city: Alicante
country: Spain
facility: Hospital General Univ. de Alicante
city: Alzira
country: Spain
facility: Hospital Univ. La Ribera
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Barakaldo
country: Spain
facility: Hospital Cruces
city: Ciudad Real
country: Spain
facility: Hospital Ciudad Real
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Getafe
country: Spain
facility: Hospital de Getafe
city: Girona
country: Spain
facility: Hospital Univ. Girona Dr. Josep Trueta
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Bellvitge
city: Jaén
country: Spain
facility: Hospital de Jaén
city: León
country: Spain
facility: Hospital Univ. León
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Univv. La Paz
city: Madrid
country: Spain
facility: Hospital Puerta del Hierro
city: Málaga
country: Spain
facility: Hospital Civil de Málaga
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias
city: Palma
country: Spain
facility: Hospital Univ. Son Espases
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Infanta Sofía
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Univ. Santiago
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Terrassa
country: Spain
facility: Hospital Univ. Alava
city: Terrassa
country: Spain
facility: Hospital Univ. Mutua de Terrassa
city: Teruel
country: Spain
facility: Hospital Obispo Polanco
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital Univ. La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Univ. Valladolid
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: