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

June 3, 2009 updated by: Ambrilia Biopharma, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Up to 96 weeks
Up to 96 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.
Time Frame: Up to 96 weeks
Up to 96 weeks
Compare plasma concentrations of C2L-OCT-01 PR.
Time Frame: First 6 months
First 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ambrilia Biopharma, Inc.

Investigators

  • Study Director: Raphael Naudin, M.D., Ambrilia Biopharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2009

Last Update Submitted That Met QC Criteria

June 3, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C2L-OCT-01 PR-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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