Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Octreotide

Criteria

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