Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Ipsen8 enrolled

Overview

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acromegaly

Interventions

Lanreotide (Autogel formulation)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of acromegaly * The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level \<10 mU/L. * The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry * Life expectancy of at least 2 years Exclusion Criteria: * Adenectomy within past 6 months, or likely during study period * Radiotherapy for acromegalic disease within 1 year, or likely during study period * Unstable concomitant dopamine agonist therapy

Locations (1)

Westmead Hospital

Westmead, New South Wales, Australia

Outcomes

Primary Outcomes

The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.

Secondary Outcomes

The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.

The percentage of patients with normalised IGF-1 compared to the baseline visit.

Change in the GH values compared to the baseline (Week 0) visit.

Change in the IGF-1 values compared to the baseline (Week 0) visit.

Change in serum lanreotide levels compared to the baseline (Week 0) visit.

Change in the serum octreotide levels compared to the baseline visit.

Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.

Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.

Data from ClinicalTrials.gov

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