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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35497
• EU PAS number:
  EUPAS35332
• Study ID:
  35497
• 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 ofneuroendocrine tumours when administered by patients or their partners (“Home Injection Group”) or administered by Healthcare Professionals
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  Objective: to assess the long-term safety, tolerability and efficacy of home injections with injections administered by a healthcare professional in patients with neuroendocrine tumours, over a period of 2-4 years and to evaluate the acceptability of home injections to patients, partners and HCPs.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 5 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 01/08/2013

Study start date

Planned: 05/08/2009

Actual: 05/08/2009

Data analysis start date

Planned: 17/12/2013

Actual: 17/12/2013

Date of final study report

Planned: 18/04/2015

Actual: 18/04/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen

Study protocol

Initial protocol

a9b52030220-protocol

Regulatory

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