Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

Novartis Pharmaceuticals28 enrolled

Overview

This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

Octreotide acetate 30 mg suspensionDRUG

Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Written voluntary informed consent. * Patients with biochemically documented active acromegaly who are currently receiving somatostatin-analogues in a conventional treatment regimen (octreotide up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months. * Patients with uncontrolled disease defined as patients with a decrease of baseline levels of growth hormone (GH) ≥ 50% during treatment with somatostatin-analogues in a conventional regimen (sandostatin up to 30 mg/28 days; lanreotide up to 120 mg/28 days) for at least 6 months. * Baseline (mean of 3 samples) GH level \> 2 µg/L. * Insulin-like Growth Factor I (IGF-I) levels above the upper limits of normal for age and gender. Other protocol-defined inclusion/exclusion criteria applied to the study.

Locations (1)

Novartis Investigative Site

Brescia, Italy

Outcomes

Primary Outcomes

Change in Growth Hormone (GH) Level From Screening to End of Study (Week 24)

Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.

Time frame: Screening to end of study (Week 24)

Change in Insulin-like Growth Factor 1 (IGF-1) Level From Screening to End of Study (Week 24)

Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.

Time frame: Screening to end of study (Week 24)

Secondary Outcomes

Change in Tumor Volume From Screening to End of Study (Week 24)

A pre-treatment magnetic resonance image (MRI) assessment of the pituitary area was required within 12 weeks prior to Screening as a baseline evaluation. A second MRI was performed at the end of the study (Week 24). All MRIs were performed according to protocol-defined guidelines. The tumor volume (mm\^3) was calculated from measurements obtained in 3 axes from the MRI images.

Time frame: Screening to end of study (Week 24)

Percentage of Participants With > 20% Tumor Shrinkage From Screening to End of Study (Week 24)

Time frame: Screening to end of study (Week 24)

Percentage of Participants Asymptomatic for Acromegaly Symptoms at Week 12 and End of Study (Week 24)

The investigator asked the participant to score the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0=absent; 1=mild; 2=moderate; 3=severe, but not disabling; 4=severe and disabling). The percentage of asymptomatic participants, ie, with a score of 0 for all symptoms, was calculated.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.