Non Interventional Post Marketing Programme in Acromegaly

Ipsen

Status: Completed

Conditions: Acromegaly

Study type: Observational

Funder types: Industry

Identifiers

NCT00747500

Y-97-52030-213

Details and patient eligibility

About

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").

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post-marketing surveillance programme and any subsequent analysis.

• The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.

• The patient must have a diagnosis of acromegaly.

• The patient must be at least 18 years of age.

• For patients receiving or intending to receive Somatuline Autogel by home injection:

  • The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their general practitioner/pharmacy on a monthly basis, or receive the medication by a home delivery service.

Exclusion criteria

• The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).