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

This study has been completed.
Sponsor:
Information provided by:
Ambrilia Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT00635765
First received: March 11, 2008
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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
Acromegaly
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00635765

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

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

ClinicalTrials.gov processed this record on April 17, 2014