Predictive Factors Study

Terminated

• Conditions: Acromegaly
• Interventions: Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.

• Registration Number: NCT02020499
• Lead Sponsor: Ipsen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Study Start: 2014-08
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acromegalic patients	Somatuline Autogel® (lanreotide) 60, 90, 120 mg.	Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)

Primary Outcome Measures

Name	Time	Method
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline	Baseline and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline	Baseline, 1 year and 3 years

Trial Locations

Locations (5)

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia

Royal Brisbane & Women's Hospital; 🇦🇺 Herston, Queensland, Australia

St Vincent's Hospital; 🇦🇺 Fitzroy, Victoria, Australia

The Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia