Who is sponsoring NCT00635765?

NCT00635765 is sponsored by Ambrilia Biopharma, Inc..

What condition does NCT00635765 study?

NCT00635765 studies Acromegaly.

What drugs are being tested in NCT00635765?

Interventions: C2L-OCT-01 PR 30 mg.

What is the status of NCT00635765?

NCT00635765 is currently COMPLETED.

Last reviewed 2009-06-03 · How we verify

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

NCT00635765 Phase 3 COMPLETED

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.

Details

Lead sponsor	Ambrilia Biopharma, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	63
Start date	2007-10
Completion	2009-06

Conditions

Acromegaly

Interventions

C2L-OCT-01 PR 30 mg

Primary outcomes

Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study. — Up to 96 weeks

Countries

Belarus, Hungary, Romania, Serbia, Slovakia, Ukraine