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NCT Number: NCT07583563

An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly

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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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinikum Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Octreotide subcutaneous depot

Drug

Commercially available octreotide subcutaneous depot treatment administered by participants for a maximum duration up to 2 years in the study

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Change in proportion of participants with IGF-1 ≤1×ULN over time.

    Time frame: From enrollment to the end of treatment at 2 years

  3. Change in GH levels over time.

    Time frame: From enrollment to the end of treatment at 2 years

  4. 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

  5. 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

    The clinician-reported AIS Overall Score ranges from 0 to 18, where a higher score indicates more severe symptoms.

  6. 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

    The AcroQoL domain scores range from 0 to 100, where a higher score indicates better quality of life.

  7. 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

    The TSQM domain scores range from 0 to 100, where a higher score indicates greater treatment satisfaction.

  8. 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

    The patient-reported AAS total score ranges from 0 to 48, where a higher score indicates more severe symptoms.

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Camurus AB

CONTACT

[email protected]

+46 46 286 57 30

Sponsors and collaborators

Lead sponsor

Camurus AB

Industry

Registry information

Official study title

A Multi-Center, Multinational, Observational Study of Octreotide Subcutaneous Depot for the Treatment of Patients With Acromegaly

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 13, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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