Brief Title
Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects
Official Title
Observational, Multicenter, Cross-sectional, Observational Study to Evaluate the Effectiveness in Routine Clinical Practice of Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) for the Treatment of Acromegaly: SOMACROL Study.
Brief Summary
The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (>4 weeks) in subjects with acromegaly in daily clinical practice.
Study Type
Observational
Primary Outcome
Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.
Secondary Outcome
Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.
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
115
Start Date
July 2016
Completion Date
September 2017
Primary Completion Date
September 2017
Eligibility Criteria
Inclusion Criteria: - Men or women aged ≥ 18 years - Diagnosed with acromegaly - Receiving treatment with ATG 120 mg at extended dosing intervals (> 4 weeks) for at least six months before the study visit. - Assay data (blood GH and IGF-1 levels) from immediately before the study visit (performed at least six months after starting the treatment) is available. - Able to sign the informed consent form for study participation. Exclusion Criteria: - Received radiation therapy treatment in the last six months. - Active participation in another clinical study. - Physical or mental disorders that, in the investigator's opinion, could affect their ability to sign the informed consent form. - Pregnancy or breastfeeding for female patients. - No data in their medical records on the treatment start date for ATG 120 mg at extended dosing intervals or on changes to the schedule of administration over the last six months.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Portugal
Location Countries
Portugal
Administrative Informations
NCT ID
NCT02807233
Organization ID
A-ES-52030-352
Secondary IDs
IPS-SOM-2015-01
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
August 2019