Predictive Factors Study

N/ATerminatedNCT02020499

Ipsen5 enrolled

Overview

This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acromegaly

Interventions

Somatuline Autogel® (lanreotide) 60, 90, 120 mg.DRUG

Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Acromegaly. * Males and females aged 18 years and older. * Signed informed consent (patient must give consent to the collection of retrospective data). * Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study. * With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG. * If already being treated with ATG: Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable). * Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly. Exclusion Criteria: * The subject has had radiotherapy in the last 5 years. * The subject has had surgery in the last 3 months. * The subject has already been included in this study. * Participation in an interventional trial, or receiving experimental drug.

Locations (6)

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Royal Brisbane & Women's Hospital

Herston, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Outcomes

Primary Outcomes

Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline

Time frame: Baseline and 4 weeks

Secondary Outcomes

Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline

Time frame: Baseline, 1 year and 3 years

Data from ClinicalTrials.gov

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