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

Ipsen

Status: Completed

Conditions: Acromegaly

Study type: Observational

Funder types: Industry

Identifiers

NCT00686348

A-TL-52030-225 (MS319)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Volunteers: No Healthy Volunteers

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)