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
Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects
Status
Completed
Phase
Not applicable
Enrollment
115
Locations
39
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
No intervention details reported.
Timeline
From registration to results.
First posted
Jun 21, 2016
Study start
Jul 2016
Primary completion
Sep 2017
Study completion
Sep 2017
Results posted
Not reported
Registry updated
Aug 5, 2019
Outcomes
What the study measures.
Primary outcomes
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
Total score and score per domain
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
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
Variations between theoretical and real treatment compliance for non-medical reasons.
Time frame · Day 1
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
39 registered sites.
Portugal · Spain. Showing up to 24 locations stored in the fast local snapshot.
Hospital de Santa Maria
Lisbon, Portugal
Centro Hospitalar Sao Jöao
Porto, Portugal
Hospital Univ. Nuestra Sra. Candelaria
Santa Cruz, Tenerife, 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
Cadiz, 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 de Jaén
Jaén, Spain
Hospital Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Univ. León
León, Spain
Hospital Arnau de Vilanova
Lleida, Spain
Hospital La Princesa
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital La Paz
Madrid, Spain
Hospital Univv. La Paz
Madrid, Spain
Hospital Puerta del Hierro
Madrid, Spain
Hospital Civil de Málaga
Málaga, Spain
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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