Trial Information
Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients
Inclusion Criteria:
- 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 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean GH and IGF-I at baseline, week 12, 24 and 48
Principal Investigator
Stephan Petersenn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universität Duisburg-Essen
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CSMS995B2401
NCT ID:
NCT00128232
Start Date:
December 2002
Completion Date:
Related Keywords:
- Acromegaly
- Acromegaly
- untreated
- newly diagnosed
- octreotide LAR
- Acromegaly