Study in Polish Acromegalic Patients Treated With Somatuline Autogel

Completed

• Conditions: Acromegaly

• Registration Number: NCT01333384
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ipsen Central Contact; 🇵🇱 Warsaw, Poland