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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02020499
Other study ID # A-9B-52030-265
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 2014
Est. completion date September 2015

Study information

Verified date January 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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