Brief Title
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
Official Title
Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.
Brief Summary
To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)
Secondary Outcome
Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Condition
Acromegaly
Intervention
Lanreotide (Autogel formulation)
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
63
Start Date
September 2000
Completion Date
July 15, 2002
Primary Completion Date
July 15, 2002
Eligibility Criteria
Inclusion Criteria: - Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions: - patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range, - patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range. Exclusion Criteria: - Patient having had pituitary surgery within the previous 3 months - Patient having received radiotherapy for acromegaly disease within the previous 36 months - Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period - Patient having received lanreotide autogel at any time before the study
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
NCT00210457
Organization ID
E-54-52030-081
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
March 2020