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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/35338
• EU PAS number:
  EUPAS35337
• Study ID:
  35338
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Australia
• Study description:
  Objective: 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 inpatients receiving their injection from a healthcare professional (HCP) (“Reference Group”).
• 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: 12/08/2008

Actual: 14/04/2009

Data analysis start date

Planned: 12/10/2012

Actual: 04/05/2013

Date of final study report

Planned: 04/01/2015

Actual: 04/01/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen

Study protocol

Initial protocol

a9b52030219-protocol

Regulatory

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