NCT00616551

Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients

Open Label, Randomized Study Comparing the Biological Efficacy & Safety of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, 30 mg Administered Every 42 Days for 84 Days With Sandostatin LAR 30 mg Administered Every 28 Days for 84 Days to Acromegalic Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Ambrilia Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	C2L-OCT-01 PR, 30 mg	Administered by deep IM injection (gluteus) on days 1 and 42
DRUG	Octreotide acetate prolonged release, 30 mg	Administered by deep IM (gluteus) on Days 1, 28 and 56

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-02-15
• Last updated: 2008-10-08

Locations

6 sites across 6 countries: Belarus, Hungary, Romania, Serbia, Slovakia, Ukraine