An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-term Safety and Efficacy of Somatuline® Autogel® in the Treatment of Acromegaly When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals (Somatuline ACRO PMS 213 study)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-marketing surveillance programme

Study drug and medical condition

• Medical condition to be studied:
  Acromegaly

Population studied

• Short description of the study population:
  Patients who were established on treatment with Somatuline Autogel for acromegaly.; Patients must satisfy all of the following entry criteria in order to be enrolled in this PMS programme:; For all patients:; • The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this PMS programme and any subsequent analysis.; • The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.; • The patient must have a diagnosis of acromegaly.; • The patient must be at least 18 years of age.; For patients receiving or intending to receive Somatuline Autogel by home injection:; • The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their GP/Pharmacy on a monthly basis, or receive the medication by a home delivery service.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Acromegaly patients
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").
• Outcomes:
  Safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional, -Efficacy of Somatuline Autogel in both groups -Training requirements for patients / partners to perform home injection of Somatuline Autogel -Acceptability of home injections to patients, partners and healthcare professionals
• Data analysis plan:
  As this is an observational programme no formal statistical analysis will be performed, and therefore no sample size calculation has been conducted. All data will be summarised descriptively by administration group and/or by dose and injection interval as appropriate.

Documents

Study results

Y-97-52030-213_synopsis_Redacted