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SODA: Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study

Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT00686348
Collaborator
(none)
260
Enrollment
1
Location
90
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The objectives of this post-marketing observational study are to assess the safety and effectiveness, as measured by insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. Treatment convenience and acromegaly symptom relief will also be assessed through questionnaires, and demographic and medical history information will be collected.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    260 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-marketing Observational Study
    Study Start Date :
    May 1, 2008
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Nov 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Assess the safety & effectiveness, as measured by IGF-1 & GH levels, of Somatuline® Depot Injection when administered by a health care professional, the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. [2 - 4 years/patient]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The patient must have a clinical diagnosis of acromegaly

    • The patient must be treated with Somatuline® Depot (including patients newly prescribed Somatuline® Depot)

    • The patient or legally authorized representative must be able to understand the protocol and give signed informed consent. Assent from the patient should also be obtained, where appropriate. Signed informed consent and assent must be obtained before any study-related activities are conducted.

    Exclusion Criteria:

    • Symptomatic, untreated biliary lithiasis

    • Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ipsen Basking Ridge New Jersey United States 07920

    Sponsors and Collaborators

    • Ipsen

    Investigators

    • Study Director: Ipsen Medical Director, Ipsen (formerly Tercica, Inc.)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ipsen
    ClinicalTrials.gov Identifier:
    NCT00686348
    Other Study ID Numbers:
    • A-TL-52030-225 (MS319)
    First Posted:
    May 29, 2008
    Last Update Posted:
    Jan 11, 2019
    Last Verified:
    Jan 1, 2019
    Keywords provided by Ipsen
    acromegaly
    Additional relevant MeSH terms:
    Acromegaly

    Study Results

    No Results Posted as of Jan 11, 2019