Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study
Information source: Tercica
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Phase: N/A
Status: Recruiting
Sponsored by: Tercica Official(s) and/or principal investigator(s):
Sandra Blethen, MD, PhD, Study Director, Affiliation: Tercica, Inc.
Overall contact:
V. Miles Rios, Jr., BS, MA, Phone: 1-866-837-2422, Email: mrios@tercica.com
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.
Clinical Details
Official title: Somatuline® Depot (Lanreotide) Injection for Acromegaly (SODA): A Post-marketing Observational Study
Study design: Other, Prospective
Primary outcome: 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.
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
V. Miles Rios, Jr., BS, MA, Phone: 1-866-837-2422, Email: mrios@tercica.com
Tercica, Inc., Brisbane, California 94005, United States; Recruiting
Additional Information
Tercica Somatuline Depot General Information
Starting date: May 2008
Ending date: June 2012
Last updated: July 14, 2009
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