Clincosm LogoSign in Get a demo

Study in Polish Acromegalic Patients Treated With Somatuline Autogel

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT01333384
Collaborator
(none)
150
Enrollment
1
Location
44
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    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
    Study Start Date :
    Oct 1, 2010
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jun 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Percentage variation of Insulin-like growth factor-1 (IGF-1) levels [24 months]

    Secondary Outcome Measures

    1. Mean growth hormone (GH) levels [24 months]

    2. Proportion of patients with GH levels below 1.0 microgram/liter [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ipsen Central Contact Warsaw Poland

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT01333384
    Other Study ID Numbers:
    • A-38-52030-739
    First Posted:
    Apr 12, 2011
    Last Update Posted:
    Jan 7, 2019
    Last Verified:
    Jan 1, 2019
    Additional relevant MeSH terms:
    Acromegaly

    Study Results

    No Results Posted as of Jan 7, 2019