Status:
COMPLETED
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 analogu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2002
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00210457
Start Date
September 1 2000
End Date
July 15 2002
Last Update
March 31 2020
Active Locations (17)
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1
Hôpital Sud
Amiens, France, 80054
2
Chu d'Angers
Angers, France, 49033
3
Hôpital de Bois Guillaume
Bois-Guillaume, France, 76233
4
Chu de la Cote de Nacre
Caen, France, 14033