A Randomised, Open-label, Multicenter Study Comparing the Efficacy and Safety of Medical Treatment With Octreotide Acetate 30 mg Administered Every 21 Days for 6 Months With That of Octreotide Acetate 60 mg Administered Every 28 Days for 6 Months in Acromegalic Patients With Uncontrolled Disease
- Written voluntary informed consent.
- Patients with biochemically documented active acromegaly who are currently receiving
somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28
days; lanreotide up to 120 mg/28 days) for at least 6 months.
- Patients with uncontrolled disease defined as patients with a decrease of baseline
levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a
conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28
days) for at least 6 months.
- Baseline (mean of 3 samples) GH level > 2 µg/L.
- Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age
Other protocol-defined inclusion/exclusion criteria applied to the study.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.
Outcome Time Frame:
Screening to end of study (Week 24)
Italy: Ethic Committee of Ospedali Civili di Brescia on behalf of National Health Authority
- octreotide acetate
- partial responder patients