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

Condition(s) targeted: Acromegaly

Intervention: Octreotide LAR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Stephan Petersenn, MD, Principal Investigator, Affiliation: Univeristat Duisburg-Essen

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.

Official title: Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Mean GH and IGF-I at baseline, week 12, 24 and 48

Secondary outcome:

Tumor volume at baseline, week 24 and 48

Signs and symptoms of acromegaly at baseline, week 12, 24 and 48

Safety and tolerability at any time on treatment

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Starting date: December 2002
Last updated: June 1, 2006