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



Status:Completed
Conditions:Skin Cancer, Endocrine
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:Any
Updated:1/13/2019
Start Date:May 2008
End Date:November 2015

Use our guide to learn which trials are right for you!

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

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.

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.

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)
We found this trial at
1
site
Basking Ridge, New Jersey 07920
?
mi
from
Basking Ridge, NJ
Click here to add this to my saved trials