Recruiting NCT07583563
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Octreotide subcutaneous depot.
- Who it may be relevant to
- Registry conditions: Acromegaly. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multi-Center, Multinational, Observational Study of Octreotide Subcutaneous Depot for the Treatment of Patients With Acromegaly
Overview
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
- Drug Octreotide subcutaneous depot
Commercially available octreotide subcutaneous depot treatment administered by participants for a maximum duration up to 2 years in the study
Primary outcome measures
- Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information. [Time frame: From enrollment to the end of treatment at 2 years]
Secondary outcome measures (9)
- Change in absolute IGF-1 levels and relative IGF-1 (IGF-1/ULN) over time. [Time frame: From enrollment to the end of treatment at 2 years]
- Change in proportion of participants with IGF-1 ≤1×ULN over time. [Time frame: From enrollment to the end of treatment at 2 years]
- Change in GH levels over time. [Time frame: From enrollment to the end of treatment at 2 years]
- Change in proportion of participants with GH levels <1.0 μg/L over time. [Time frame: 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. [Time frame: 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). [Time frame: 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). [Time frame: 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. [Time frame: 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. [Time frame: From enrollment to the end of treatment at 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 5 centers
- Universitaetsklinikum Aachen — Aachen
- Universitaetsklinikum Leipzig — Leipzig
- Fachpraxis für Innere Medizin, Endokrinologie und Diabetologie — Magdeburg
- Medicover Neuroendokrinologie MVZ — München
- Universitätsklinikum Würzburg — Würzburg
Identifiers
NCT: NCT07583563 · HS-24-799