Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly
| Status: | Terminated |
|---|---|
| Conditions: | Skin Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/1/2019 |
| Start Date: | October 2009 |
| End Date: | February 2011 |
Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients
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 patients with acromegaly after 6 months of treatment.
injections at different doses of BIM 23A760 on growth hormone and insulin-like growth
factor-1 levels in patients with acromegaly after 6 months of treatment.
Inclusion Criteria:
- 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 Criteria:
- 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
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