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
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.
Investigators
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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