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

Completed

• Conditions: Acromegaly

• Registration Number: NCT00686348
• Lead Sponsor: Ipsen

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-05-29
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2 - 4 years/patient

Trial Locations

Locations (1)

Ipsen; 🇺🇸 Basking Ridge, New Jersey, United States