Acromegaly
Conditions
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 analogues.
Interventions
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean growth hormone (GH) levels | — |
| Number of patients having a serum GH level at or below 2.5ng/ml | — |
| Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range | — |
| Number of patients with no or reduced clinical signs of acromegaly | — |
| Long-term safety of repeated injections of lanreotide autogel at titrated doses | — |
| Number of patients having a serum GH level at or below 1 ng/ml | — |
Countries
France, Switzerland
Outcome results
None listed