Status:
COMPLETED
Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.
Eligibility Criteria
Inclusion
- Clinical diagnosis of acromegaly
- The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level \<10 mU/L.
- The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
- Life expectancy of at least 2 years
Exclusion
- Adenectomy within past 6 months, or likely during study period
- Radiotherapy for acromegalic disease within 1 year, or likely during study period
- Unstable concomitant dopamine agonist therapy
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2006
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00216398
Start Date
June 1 2004
End Date
June 22 2006
Last Update
August 16 2019
Active Locations (1)
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1
Westmead Hospital
Westmead, New South Wales, Australia, 2145