NCT00686348

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 260 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acromegaly

Timeline

• Start date: 2008-05-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2008-05-29
• Last updated: 2019-01-11

Locations

1 site across 1 country: United States