Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects
- Conditions
- Acromegaly
- Registration Number
- NCT02807233
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit. Day 1
- Secondary Outcome Measures
Name Time Method 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 Percentage of subjects whose dosing regimen has been changed in the six months before the study. Day 1 Preference for self-administered injections or administration in an outpatient clinic by a medical professional. Day 1 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 EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals. Day 1 Total score and score per domain
Variations between theoretical and real treatment compliance for non-medical reasons. Day 1 Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals. Day 1 Total score and score per domain
Treatment Satisfaction Questionnaire for Medication-9 (TSMQ-9) in subjects treated with ATG 120 mg at extended dosing intervals after ≥ 5 months. Day 1 Total score and score per domain
Trial Locations
- Locations (39)
Hospital Univ. Príncipe de Asturias
🇪🇸Alcalá de Henares, Spain
Hospital Univ. Nuestra Sra. Candelaria
🇪🇸Santa Cruz, Tenerife, Spain
Complejo Hospitalario Univ. A Coruña
🇪🇸A Coruña, Spain
Hospital General Univ. de Alicante
🇪🇸Alicante, Spain
Hospital Univ. La Ribera
🇪🇸Alzira, Spain
Hospital Infanta Cristina
🇪🇸Badajoz, Spain
Hospital Cruces
🇪🇸Barakaldo, Spain
Hospital Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Puerta del Mar
🇪🇸Cádiz, Spain
Hospital Reina Sofía
🇪🇸Córdoba, Spain
Hospital de Getafe
🇪🇸Getafe, Spain
Hospital Univ. Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital de Jaén
🇪🇸Jaén, Spain
Hospital Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Hospital Univ. León
🇪🇸León, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Univ. Central de Asturias
🇪🇸Oviedo, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Univv. La Paz
🇪🇸Madrid, Spain
Hospital Civil de Málaga
🇪🇸Málaga, Spain
Hospital Puerta del Hierro
🇪🇸Madrid, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Spain
Hospital Univ. Son Espases
🇪🇸Palma, Spain
Hospital Univ. Alava
🇪🇸Terrassa, Spain
Hospital Infanta Sofía
🇪🇸San Sebastian de los Reyes, Spain
Hospital Clínico Univ. Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Univ. Mutua de Terrassa
🇪🇸Terrassa, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Hospital Obispo Polanco
🇪🇸Teruel, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Hospital Univ. La Fe
🇪🇸Valencia, Spain
Hospital Clínico Univ. Valladolid
🇪🇸Valladolid, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Centro Hospitalar Sao Jöao
🇵🇹Porto, Portugal
Hospital de Santa Maria
🇵🇹Lisboa, Portugal