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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00635765
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : June 4, 2009
Information provided by:
Ambrilia Biopharma, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: C2L-OCT-01 PR 30 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Compare plasma concentrations of C2L-OCT-01 PR. [ Time Frame: First 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00635765

Republican Centre for Medical Rehabilitation and Water-therapy
Minsk, Belarus
Semmelweis Egyetem Altalanos Orvostudomanyi
Budapest, Hungary
Institue of Endocrinology "C.I Parhon" Bucharest
Bucharest, Romania
Institute of Endocrinology, University Clinical Center
Belgrade, Serbia
Fakultna Nemocnica s Poliklinkow Bratislava
Bratislava, Slovakia
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Kiev, Ukraine
Sponsors and Collaborators
Ambrilia Biopharma, Inc.
Study Director: Raphael Naudin, M.D. Ambrilia Biopharma, Inc.

Responsible Party: Bonabes de Rouge, M.D./Senior Executive Vice-President & Chief Scientist Officer, Ambrilia Biopharma, Inc. Identifier: NCT00635765     History of Changes
Other Study ID Numbers: C2L-OCT-01 PR-302
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Keywords provided by Ambrilia Biopharma, Inc.:

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases