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

Novartis

Status and phase

Completed

Phase 3

Conditions

Acromegaly

Treatments

Drug: Octreotide LAR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00128232

CSMS995B2401

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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