Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

• Status: Completed
• Trial end date: 2002-07-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Angiopeptin; Lanreotide; Somatostatin

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