Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
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
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 uncontrolled disease.
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
Change in Tumor Volume From Screening to End of Study (Week 24)
Octreotide acetate 30 mg suspension
Study Arms / Comparison Groups
Octreotide 30 mg every 21 days
Description: Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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.
18 Years - 80 Years
Accepts Healthy Volunteers
Novartis, Study Chair, Novartis