Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
The purpose of the study is to assess the efficacy of an extended injection interval schedule
 of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long
 term treatment with octreotide LAR 10 or 20 mg
Inclusion Criteria:

 -  The subject has given written informed consent prior to any study-related procedures

 -  The subject is male or female and is over 18 years of age

 -  The subject must have had documentation supporting the diagnosis of acromegaly, based
 on elevated IGF-1 and/or GH levels

 -  The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six
 months and is biochemically controlled. Control is defined as normal (age and sex
 adjusted) IGF 1 levels for two consecutive measurements (at least two months apart)
 preceding study entry

 -  If the subject is receiving dopamine agonist therapy, treatment should be stable for
 at least four months, and no change in their dopamine-agonist medication is expected
 during the entire study period

 Exclusion Criteria:

 -  The subject has received radiation therapy to the pituitary gland before study entry

 -  The subject has a history of hypersensitivity to lanreotide or drugs with a similar
 chemical structure

 -  The subject has received a growth hormone receptor antagonist (pegvisomant) therapy
 within three months before study entry

 -  The subject has undergone treatment with any other investigational drug in the 30 days
 before study entry or is scheduled to receive an investigational drug, other than
 lanreotide 120 mg, during the course of the study

 -  The subject has received any unlicensed drug within the 30 days prior to the baseline
 visit or is scheduled to receive an unlicensed drug during the course of the study