Study in Polish Acromegalic Patients Treated With Somatuline Autogel

A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01333384

Enrollment

150

Registered

2011-04-12

Start date

2010-10-31

Completion date

2014-06-30

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Brief summary

The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg * Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available

Exclusion criteria

* Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an

Design outcomes

Primary

Measure	Time frame
Percentage variation of Insulin-like growth factor-1 (IGF-1) levels	24 months

Secondary

Measure	Time frame
Mean growth hormone (GH) levels	24 months
Proportion of patients with GH levels below 1.0 microgram/liter	24 months

Countries

Poland

Outcome results