Status:
COMPLETED
Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
Lead Sponsor:
Novartis
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. Octreotide LAR is approved for treatme...
Eligibility Criteria
Inclusion
- Newly diagnosed or previously untreated acromegalic patients
- Lack of suppression of growth hormone (GH) nadir to \<1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test \[OGTT\])
- Insulin-like growth factor-I (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
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00128232
Start Date
December 1 2002
Last Update
April 30 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.