Status:
COMPLETED
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontroll...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 and gender.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00372697
Start Date
December 1 2005
End Date
October 1 2007
Last Update
May 17 2011
Active Locations (1)
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1
Novartis Investigative Site
Brescia, Italy