Predictive Factors Study

Acromegaly Clinical Trial

— TAPAS  

Official title:

Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02020499
• Other study ID #: A-9B-52030-265
• Status: Terminated
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.

Locations

Country	Name	City	State
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	St Vincent's Hospital	Fitzroy	Victoria
Australia	The Austin Hospital	Heidelberg	Victoria
Australia	Royal Brisbane & Women's Hospital	Herston	Queensland
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline		Baseline and 4 weeks
Secondary	Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline		Baseline, 1 year and 3 years