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

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635765
• Other study ID #: C2L-OCT-01 PR-302
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2008
• Last updated: June 3, 2009
• Start date: October 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Ambrilia Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRomania: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

•Subjects who have completed the 24-week C2L-OCT-01 PR-301 study

Exclusion Criteria:

• Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating

• Subjects who have experienced any clinically significant adverse event related to study medication in C2L-OCT-01 PR-301 study

• Subjects with uncontrolled Diabetes type II

• Subjects with signs or symptoms related to a tumor compression of the optical chiasm

• Subjects with symptomatic cholelithiasis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly

Intervention

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.

Locations

Country	Name	City	State
Belarus	Republican Centre for Medical Rehabilitation and Water-therapy	Minsk
Hungary	Semmelweis Egyetem Altalanos Orvostudomanyi	Budapest
Romania	Institue of Endocrinology "C.I Parhon" Bucharest	Bucharest
Serbia	Institute of Endocrinology, University Clinical Center	Belgrade
Slovakia	Fakultna Nemocnica s Poliklinkow Bratislava	Bratislava
Ukraine	V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Ambrilia Biopharma, Inc.

Countries where clinical trial is conducted

Belarus,  Hungary,  Romania,  Serbia,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.		Up to 96 weeks	Yes
Secondary	Compare plasma concentrations of C2L-OCT-01 PR.		First 6 months	Yes