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

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

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

Official Title

Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-marketing Observational Study

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.

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 Type

Observational

Primary Outcome

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.

Condition

Acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

260

Start Date

May 2008

Completion Date

November 2015

Primary Completion Date

November 2015

Eligibility Criteria

        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)

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00686348

Organization ID

A-TL-52030-225 (MS319)

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

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

Verification Date

January 2019