Brief Title
Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly
Official Title
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
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 uncontrolled disease.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)
Secondary Outcome
Change in Tumor Volume From Screening to End of Study (Week 24)
Condition
Acromegaly
Intervention
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
28
Start Date
December 2005
Completion Date
October 2007
Primary Completion Date
October 2007
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Novartis, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00372697
Organization ID
CSMS995BIT12
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis, Study Chair, Novartis
Verification Date
April 2011