Status:
COMPLETED
Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
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 ...
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®...
Eligibility Criteria
Inclusion
- 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
- Symptomatic, untreated biliary lithiasis
- Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00686348
Start Date
May 1 2008
End Date
November 1 2015
Last Update
January 11 2019
Active Locations (1)
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1
Ipsen
Basking Ridge, New Jersey, United States, 07920