Status:
COMPLETED
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to asse...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00225979
Start Date
November 1 2002
End Date
March 1 2005
Last Update
April 11 2012
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