Non Interventional Post Marketing Programme in Acromegaly

Completed

• Conditions: Acromegaly

• Registration Number: NCT00747500
• Lead Sponsor: Ipsen

Brief Summary

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").

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Primary Completion: 2012-09
• Study Completion: 2013-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional	End of observational period

Secondary Outcome Measures

Name	Time	Method
training requirements for patients / partners to perform home injection of Somatuline Autogel	End of observational period
efficacy of Somatuline Autogel in both groups	End of observational period
acceptability of home injections to patients, partners and healthcare professionals	End of observational period

Trial Locations

Locations (7)

University Hospital Coventry & Warwickshire; 🇬🇧 Coventry, United Kingdom

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Barnsley General Hospital; 🇬🇧 Barnsley, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Churchill Hospital; 🇬🇧 Oxford, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom