Brief Title
Predictive Factors Study
Official Title
Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.
Brief Summary
This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.
Study Type
Observational
Primary Outcome
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Secondary Outcome
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Condition
Acromegaly
Intervention
Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
Study Arms / Comparison Groups
Acromegalic patients
Description: Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
5
Start Date
August 2014
Completion Date
September 2015
Primary Completion Date
September 2015
Eligibility Criteria
Inclusion Criteria: - Diagnosis of Acromegaly. - Males and females aged 18 years and older. - Signed informed consent (patient must give consent to the collection of retrospective data). - Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study. - With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG. - If already being treated with ATG: Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable). - Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly. Exclusion Criteria: - The subject has had radiotherapy in the last 5 years. - The subject has had surgery in the last 3 months. - The subject has already been included in this study. - Participation in an interventional trial, or receiving experimental drug.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02020499
Organization ID
A-9B-52030-265
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
January 2019