Brief Title
Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly
Official Title
Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly
Brief Summary
The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Growth hormone assessment
Secondary Outcome
Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments
Condition
Acromegaly
Intervention
lanreotide (Autogel formulation), duration of treatment 46-48 weeks
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
January 2001
Completion Date
May 2003
Eligibility Criteria
Inclusion Criteria: - Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values Exclusion Criteria: - Patients who have undergone pituitary surgery less than 3 months before selection - Patients previously treated with radiotherapy - Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00499993
Organization ID
A-93-52030-077
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
January 2019