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

This study has been completed.
Information provided by:
Ambrilia Biopharma, Inc. Identifier:
First received: March 11, 2008
Last updated: June 3, 2009
Last verified: June 2009

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 Intervention Phase
Drug: C2L-OCT-01 PR 30 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Ambrilia Biopharma, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Compare plasma concentrations of C2L-OCT-01 PR. [ Time Frame: First 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 63
Study Start Date: October 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: 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.
  More Information

No publications provided

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
Study First Received: March 11, 2008
Last Updated: June 3, 2009
Health Authority: United States: Food and Drug Administration
Romania: Ministry of Public Health

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 processed this record on April 17, 2014