Brief Title
Study in Polish Acromegalic Patients Treated With Somatuline Autogel
Official Title
A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval
Brief Summary
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.
Study Type
Observational
Primary Outcome
Percentage variation of Insulin-like growth factor-1 (IGF-1) levels
Secondary Outcome
Mean growth hormone (GH) levels
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
150
Start Date
October 2010
Completion Date
June 2014
Primary Completion Date
June 2014
Eligibility Criteria
Inclusion Criteria: - Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg - Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available Exclusion Criteria: - Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Poland
Location Countries
Poland
Administrative Informations
NCT ID
NCT01333384
Organization ID
A-38-52030-739
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
January 2019