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The purpose of this study is to collect long-term (up to two years) safety and effectiveness of octreotide subcutaneous depot in patients with acromegaly in the real-world setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide subcutaneous depot | Drug | Commercially available octreotide subcutaneous depot treatment administered by participants for a maximum duration up to 2 years in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information. | From enrollment to the end of treatment at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in absolute IGF-1 levels and relative IGF-1 (IGF-1/ULN) over time. | From enrollment to the end of treatment at 2 years | |
| Change in proportion of participants with IGF-1 ≤1×ULN over time. | From enrollment to the end of treatment at 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll patients with acromegaly who are considered for treatment with octreotide subcutaneous depot and patients with acromegaly who have already initiated octreotide subcutaneous depot treatment. The study will be conducted in Germany, the UK, and the US.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Camurus AB | Contact | +46 46 286 57 30 | medicalinfo@camurus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Aachen | Not yet recruiting | Aachen | 52074 | Germany | ||
| Universitaetsklinikum Leipzig |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| Change in GH levels over time. | From enrollment to the end of treatment at 2 years |
| Change in proportion of participants with GH levels <1.0 μg/L over time. | From enrollment to the end of treatment at 2 years |
| Changes in symptoms of acromegaly over time, as measured by the Acromegaly Index of Severity (AIS) scale. | The clinician-reported AIS Overall Score ranges from 0 to 18, where a higher score indicates more severe symptoms. | From enrollment to the end of treatment at 2 years |
| Changes in QoL over time, as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL). | The AcroQoL domain scores range from 0 to 100, where a higher score indicates better quality of life. | From enrollment to the end of treatment at 2 years |
| Changes in QoL over time, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM). | The TSQM domain scores range from 0 to 100, where a higher score indicates greater treatment satisfaction. | From enrollment to the end of treatment at 2 years |
| Changes in QoL over time, as measured by the Assessment of Acromegaly Symptoms (AAS) questionnaire. | The patient-reported AAS total score ranges from 0 to 48, where a higher score indicates more severe symptoms. | From enrollment to the end of treatment at 2 years |
| Incidence of octreotide SC depot non-related AEs and incidence of laboratory abnormalities using the CTCAE grading scale. | From enrollment to the end of treatment at 2 years |
| Recruiting |
| Leipzig |
| 04103 |
| Germany |
| Fachpraxis für Innere Medizin, Endokrinologie und Diabetologie | Not yet recruiting | Magdeburg | 39110 | Germany |
| Medicover Neuroendokrinologie MVZ | Not yet recruiting | München | 81667 | Germany |
| Universitätsklinikum Würzburg | Not yet recruiting | Würzburg | 97080 | Germany |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |