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| ID | Type | Description | Link |
|---|---|---|---|
| IPS-SOM-2015-01 | Other Identifier | Spanish Drug Agency AEMPS |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Hospital patients
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal | |||
| Centro Hospitalar Sao Jöao |
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| 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 |
| 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 |
| 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 |
| 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 |
| Variations between theoretical and real treatment compliance for non-medical reasons. | Day 1 |
| Porto |
| 4200-319 |
| Portugal |
| Hospital Univ. Nuestra Sra. Candelaria | Santa Cruz | Tenerife | 38010 | Spain |
| Complejo Hospitalario Univ. A Coruña | A Coruña | 15006 | Spain |
| Hospital Univ. Príncipe de Asturias | Alcalá de Henares | 28805 | Spain |
| Hospital General Univ. de Alicante | Alicante | 03010 | Spain |
| Hospital Univ. La Ribera | Alzira | 46600 | Spain |
| Hospital Infanta Cristina | Badajoz | 06006 | Spain |
| Hospital Cruces | Barakaldo | 48903 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital Ciudad Real | Ciudad Real | 13005 | Spain |
| Hospital Reina Sofía | Córdoba | 14004 | Spain |
| Hospital de Getafe | Getafe | 28905 | Spain |
| Hospital Univ. Girona Dr. Josep Trueta | Girona | 17007 | Spain |
| Hospital de Jaén | Jaén | 23005 | Spain |
| Hospital Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Univ. León | León | 24001 | Spain |
| Hospital Arnau de Vilanova | Lleida | 25198 | Spain |
| Hospital La Princesa | Madrid | 28006 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Univv. La Paz | Madrid | 28046 | Spain |
| Hospital Puerta del Hierro | Madrid | 28222 | Spain |
| Hospital Civil de Málaga | Málaga | 29009 | Spain |
| Hospital Virgen de la Victoria | Málaga | 29010 | Spain |
| Hospital Univ. Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Univ. Son Espases | Palma | 07120 | Spain |
| Corporacio Sanitaria Parc Tauli | Sabadell | 08208 | Spain |
| Hospital Infanta Sofía | San Sebastián de los Reyes | 28702 | Spain |
| Hospital Clínico Univ. Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Virgen del Rocío | Seville | 41013 | Spain |
| Hospital Univ. Alava | Terrassa | 08221 | Spain |
| Hospital Univ. Mutua de Terrassa | Terrassa | 08221 | Spain |
| Hospital Obispo Polanco | Teruel | 44002 | Spain |
| Hospital Virgen de la Salud | Toledo | 45005 | Spain |
| Hospital Clínico de Valencia | Valencia | 46010 | Spain |
| Hospital Univ. La Fe | Valencia | 46026 | Spain |
| Hospital Clínico Univ. Valladolid | Valladolid | 47003 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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