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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Acromegaly
Both
Acromegaly
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Growth hormone assessment
Outcome Time Frame:
At every visit
Principal Investigator
Paolo Boscani, MD
Investigator Role:
Study Director
Investigator Affiliation:
Ipsen
Authority:
Italy: Ministry of Health
Study ID:
A-93-52030-077
NCT ID:
NCT00499993
Start Date:
January 2001
Completion Date:
May 2003
Related Keywords:
- Acromegaly
- Acromegaly
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