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