An Observational, multicentre, open label, non interventional programme to assess the long-term safety and efficacy of Somatuline® Autogel® in the treatment of neuroendocrine tumours when administered by patients or their partners (“Home Injection Group”) or administered by Healthcare Professionals (Somatuline NET PMS 215 study)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30177
• EU PAS number:
  EUPAS7986
• Study ID:
  30177
• Official title and acronym:
  An Observational, multicentre, open label, non interventional programme to assess the long-term safety and efficacy of Somatuline® Autogel® in the treatment of neuroendocrine tumours when administered by patients or their partners (“Home Injection Group”) or administered by Healthcare Professionals (Somatuline NET PMS 215 study)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A two year observational study wherein enrolled patients have a diagnosis of NET and have been established on a stable dose of Somatuline Autogel for at least 4 months before entering the programme. The dose and interval between injections will have been determined by the treating clinician in accordance with usual clinical practice. Patients enrolled in this PMS programme may receive their injections from a HCP, or by home injection. Patients receiving home injections will enter the “Home Injection Group”. Patients receiving their injections from a Healthcare Professional (HCP) will form a “Reference Group”. The number of patients enrolled into each group is not mandated
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 7 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 29/09/2008

Actual: 29/09/2008

Study start date

Planned: 02/03/2009

Actual: 02/03/2009

Date of final study report

Planned: 23/12/2014

Actual: 18/02/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen Ltd

Study protocol

Initial protocol

Y-97-52030-215 v1.2 15Oct12_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable