Acromegaly
Conditions
Keywords
Octreotide subcutaneous depot, Acromegaly, Observational, Real-world, Safety, Tolerability
Brief summary
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.
Interventions
DRUGOctreotide subcutaneous depot
Commercially available octreotide subcutaneous depot treatment administered by participants for a maximum duration up to 2 years in the study
Sponsors
Camurus AB
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have started or will be starting treatment with octreotide SC depot for acromegaly
Exclusion criteria
* Have started or will be starting treatment with octreotide SC depot for other conditions not related to acromegaly * Currently taking part in an interventional clinical trial or is still within a 30-day washout period from the end of taking part in an interventional clinical trial.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. | From enrollment to the end of treatment at 2 years | The clinician-reported AIS Overall Score ranges from 0 to 18, where a higher score indicates more severe symptoms. |
| Changes in QoL over time, as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL). | From enrollment to the end of treatment at 2 years | The AcroQoL domain scores range from 0 to 100, where a higher score indicates better quality of life. |
| Changes in QoL over time, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM). | From enrollment to the end of treatment at 2 years | The TSQM domain scores range from 0 to 100, where a higher score indicates greater treatment satisfaction. |
| Changes in QoL over time, as measured by the Assessment of Acromegaly Symptoms (AAS) questionnaire. | From enrollment to the end of treatment at 2 years | The patient-reported AAS total score ranges from 0 to 48, where a higher score indicates more severe symptoms. |
| 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 | — |
Countries
Germany, United Kingdom
Contacts
CONTACTCamurus AB
Outcome results
None listed