Status:
TERMINATED
Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
Lead Sponsor:
Ipsen
Conditions:
Acromegaly
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin) injections at different doses of BIM 23A760 on growth hormone and insulin-like growth factor-1 levels in p...
Eligibility Criteria
Inclusion
- IGF-1 ≥1.3 x upper limit normal (ULN)
- Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)
- Patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.
Exclusion
- The patient has received long acting somatostatin analogues within 6 months of study entry
- The patient has undergone radiotherapy at any time prior to study entry
- The time between pituitary surgery (if any) and study entry is less than 6 weeks
- The patient suffers from macroadenoma with visual field defects due to chiasmatic compression
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00994214
Start Date
October 1 2009
End Date
February 1 2011
Last Update
November 22 2019
Active Locations (23)
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1
Pituitary Center
Los Angeles, California, United States, 90048
2
Massachusetts General Hospital / Neuroendocrine Unit
Boston, Massachusetts, United States, 02114
3
Oregon University, Dept. of Endocrinology and Neurosurgery
Portland, Oregon, United States, 97239
4
UZ Leuven
Leuven, Belgium, 3000