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

Acromegaly Clinical Trial

— SODA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686348
• Other study ID #: A-TL-52030-225 (MS319)
• Status: Completed
• Start date: May 2008
• Est. completion date: November 2015

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acromegaly

Locations

Country	Name	City	State
United States	Ipsen	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Tercica Somatuline Depot General Information