Brief Title
Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg
Official Title
Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg
Brief Summary
The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.
Study Type
Observational
Primary Outcome
Percentage of subjects who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase.
Secondary Outcome
Profile of subjects
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
4
Start Date
January 2016
Completion Date
June 2016
Primary Completion Date
January 2016
Eligibility Criteria
Inclusion Criteria: - Male or female aged 18 years or more, suffering from acromegaly - Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA) - Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects) - In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy Exclusion Criteria: - Subject previously/currently treated with Lanreotide 120mg - History of radiotherapy for acromegaly - Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression - Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists - Active neoplastic disease
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02698384
Organization ID
A-54-52030-315
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
December 2018