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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/30180
• EU PAS number:
  EUPAS7982
• Study ID:
  30180
• 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 Acromegaly When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals (Somatuline ACRO PMS 213 study)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  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").
• 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: 26/04/2008

Actual: 26/04/2008

Study start date

Planned: 11/09/2008

Actual: 11/11/2008

Date of final study report

Planned: 17/12/2014

Actual: 12/02/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen Ltd.

Study protocol

Initial protocol

Y-97-52030-213 v1.2_Redacted

Regulatory

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