Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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 patients with acromegaly after 6 months of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Dopamine; Somatostatin

Criteria

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