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 summary

No information provided.

Study identification

• 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.

Regulatory

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