Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study
SODA
1 other identifier
observational
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
May 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJanuary 11, 2019
January 1, 2019
7.5 years
May 27, 2008
January 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Patients with a clinical diagnosis of acromegaly
You may qualify if:
- 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.
You may not qualify if:
- Symptomatic, untreated biliary lithiasis
- Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (1)
Ipsen
Basking Ridge, New Jersey, 07920, United States
Related Publications (1)
Salvatori R, Gordon MB, Woodmansee WW, Ioachimescu AG, Carver DW, Mirakhur B, Cox D, Molitch ME. A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry. Pituitary. 2017 Dec;20(6):605-618. doi: 10.1007/s11102-017-0821-y.
PMID: 28741071DERIVED
Related Links
Biospecimen
Routine clinical laboratory assessments will be performed: GH and IGF-1
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen (formerly Tercica, Inc.)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2008
First Posted
May 29, 2008
Study Start
May 1, 2008
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
January 11, 2019
Record last verified: 2019-01