Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Phase 3
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Both
Acromegaly
Both
Acromegaly
Trial Information
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Inclusion Criteria:
- Newly diagnosed or previously untreated acromegalic patients
- Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of
glucose (OGTT)
- IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age
and gender)
Exclusion Criteria:
- Requires surgery for recent significant deterioration in visual fields or other
neurological signs, which are related to the pituitary tumor mass
- No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI)
- Symptomatic cholelithiasis
Other protocol-defined exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean GH and IGF-I at baseline, week 12, 24 and 48
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Italy: Ministry of Health
Study ID:
CSMS995B2402
NCT ID:
NCT00225979
Start Date:
November 2002
Completion Date:
March 2005
Related Keywords:
- Acromegaly
- Acromegaly
- Untreated
- Newly diagnosed
- Octreotide LAR
- Pituitary surgery
- Acromegaly
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