Non Interventional Post Marketing Programme in Acromegaly

Acromegaly Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747500
• Other study ID #: Y-97-52030-213
• Status: Completed
• Start date: July 2008
• Est. completion date: March 2013

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Barnsley General Hospital	Barnsley
United Kingdom	University Hospital Coventry & Warwickshire	Coventry
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Churchill Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional		End of observational period
Secondary	efficacy of Somatuline Autogel in both groups		End of observational period
Secondary	training requirements for patients / partners to perform home injection of Somatuline Autogel		End of observational period
Secondary	acceptability of home injections to patients, partners and healthcare professionals		End of observational period