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

Acromegaly Clinical Trial

— SOMACROL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807233
• Other study ID #: A-ES-52030-352
• Secondary ID: IPS-SOM-2015-01
• Status: Completed
• Start date: July 2016
• Est. completion date: September 2017

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Centro Hospitalar Sao Jöao	Porto
Spain	Complejo Hospitalario Univ. A Coruña	A Coruña
Spain	Hospital Univ. Príncipe de Asturias	Alcalá de Henares
Spain	Hospital General Univ. de Alicante	Alicante
Spain	Hospital Univ. La Ribera	Alzira
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Cruces	Barakaldo
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital Ciudad Real	Ciudad Real
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital de Getafe	Getafe
Spain	Hospital Univ. Girona Dr. Josep Trueta	Girona
Spain	Hospital Bellvitge	Hospitalet de Llobregat
Spain	Hospital de Jaén	Jaén
Spain	Hospital Univ. León	León
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Puerta del Hierro	Madrid
Spain	Hospital Univv. La Paz	Madrid
Spain	Hospital Civil de Málaga	Málaga
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Univ. Central de Asturias	Oviedo
Spain	Hospital Univ. Son Espases	Palma
Spain	Corporacio Sanitaria Parc Tauli	Sabadell
Spain	Hospital Infanta Sofía	San Sebastian de los Reyes
Spain	Hospital Univ. Nuestra Sra. Candelaria	Santa Cruz	Tenerife
Spain	Hospital Clínico Univ. Santiago	Santiago de Compostela
Spain	Hospital Virgen del Rocío	Sevilla
Spain	Hospital Univ. Alava	Terrassa
Spain	Hospital Univ. Mutua de Terrassa	Terrassa
Spain	Hospital Obispo Polanco	Teruel
Spain	Hospital Virgen de la Salud	Toledo
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital Univ. La Fe	Valencia
Spain	Hospital Clínico Univ. Valladolid	Valladolid
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.		Day 1
Secondary	Percentage of subjects with Growth hormone (GH) levels = 2.5 ng/mL or = 1 ng/mL in the assay before the study visit.		Day 1
Secondary	Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for = 6 months with dosing intervals of five, six, seven or eight weeks.		Day 1
Secondary	Percentage of subjects whose dosing regimen has been changed in the six months before the study.		Day 1
Secondary	Preference for self-administered injections or administration in an outpatient clinic by a medical professional.		Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	Variations between theoretical and real treatment compliance for non-medical reasons.		Day 1