An Observational, Multicentre, Open label, Post-Marketing Surveillance Program 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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  LANREOTIDE ACETATE
• Anatomical Therapeutic Chemical (ATC) code:
  (H01CB03) lanreotide

  lanreotide
• Medical condition to be studied:
  Acromegaly

Population studied

• Short description of the study population:
  Approximately 30 patients who are established on treatment with Somatuline Autogel for acromegaly. All eligible patients at participating centres can enrol in this PMS programme if both they and the clinical staff are willing to do so.; Patients MUST satisfy all of the following entry criteria in order to be enrolled in this PMS programme.; Inclusion Criteria:; For all patients:; 1. 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.; 2. The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.; 3. The patient must have a diagnosis of acromegaly.; 4. The patient must be at least 18 years of age.; For patients receiving or intending to receive Somatuline Autogel by home injection:; 5. 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.; Exclusion Criteria:; For all patients:; 1. The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).
• 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:
  38

Study design details

• Main study objective:
  To assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners.
• Outcomes:
  To assess the long-term safety following parameters will be evaluated: Incidence of adverse events (AEs) and serious adverse events (SAEs), Concomitant medications / therapies / surgical procedures. The incidence of local injection site tolerability through patient reported comments, The efficacy endpoints: GH plasma levels, IGF-1 plasma levels, Tumour size, Acromegaly symptoms.
• Data analysis plan:
  As this is an observational program 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

a9b52030219-synopsis