Brief Title
Non Interventional Post Marketing Programme in Acromegaly
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.
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").
Study Type
Observational
Primary Outcome
safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional
Secondary Outcome
efficacy of Somatuline Autogel in both groups
Condition
Acromegaly
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
42
Start Date
July 2008
Completion Date
March 2013
Primary Completion Date
September 2012
Eligibility Criteria
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).
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT00747500
Organization ID
Y-97-52030-213
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
January 2019