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

Novartis

Status and phase: Completed; Phase 3

Conditions: Acromegaly

Treatments: Drug: Octreotide LAR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00225979

CSMS995B2402

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. 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.

Enrollment: 100 patients

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 1 patient group

SMS995

Experimental group

Treatment:

Drug: Octreotide LAR