NCT00635765

Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients

Open Label Extension Study Evaluating the Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, Administered Intra Muscularly Every 6, 5 or 4 Weeks in Acromegalic Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (estimated)
• 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 safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	C2L-OCT-01 PR 30 mg	Administered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-03-14
• Last updated: 2009-06-04

Locations

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