Acromegaly
Conditions
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.
Interventions
DRUGlanreotide (Autogel formulation), duration of treatment 46-48 weeks
Sponsors
Ipsen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth hormone assessment | At every visit |
Secondary
| Measure | Time frame |
|---|---|
| Prolactin (PRL) assessment | At study inclusion, visit 1 and at the final visit of the study |
| Lanreotide assessment | At every visit |
| Clinical symptoms | At every visit |
| Quality of life | At visit 1 and at the final visit of the study |
| Safety assessment evaluated by clinical data | At every visit |
| Evaluation of carotid vessels (on an optional basis) | At inclusion and at the final visit of the study |
| Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments | At every visit (with the exception of ALS at study inclusion) |
| Safety assessment evaluated by laboratory data | At inclusion visit and at the final visit of the study |
| Tumour size | At inclusion and at the final visit of the study |
Countries
Italy
Outcome results
None listed