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Clinical Trials/NCT01333384
NCT01333384
Completed
N/A

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

Ipsen1 site in 1 country150 target enrollmentOctober 2010
ConditionsAcromegaly

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acromegaly
Sponsor
Ipsen
Enrollment
150
Locations
1
Primary Endpoint
Percentage variation of Insulin-like growth factor-1 (IGF-1) levels
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
June 2014
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ipsen
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage variation of Insulin-like growth factor-1 (IGF-1) levels

Time Frame: 24 months

Secondary Outcomes

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

Study Sites (1)

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