Clinical Trial: Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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 Summary: 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.
Sponsor: Ipsen
Current 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. [ Time Frame: 2 - 4 years/patient ]
Original 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. [ Time Frame: 2 years/patient ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Ipsen
Dates:
Date Received: May 27, 2008
Date Started: May 2008
Date Completion:
Last Updated: May 27, 2016
Last Verified: May 2016