Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Novartis Pharmaceuticals100 enrolled

Overview

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Acromegaly

Interventions

Octreotide LARDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Newly diagnosed or previously untreated acromegalic patients * Lack of suppression of GH nadir to \<1.0 µg/L, after oral administration of 75 g of glucose (OGTT) * 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 Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Tumor volume at baseline, week 24 and 48

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

Quality of life and sleep apnea at baseline, week 12, 24 and 48

Safety and tolerability at any time on treatment

Data from ClinicalTrials.gov

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