Back to resultsOpen Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
C2L-OCT-01 PR 30 mg
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly
Eligibility 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
Sites / Locations
- Republican Centre for Medical Rehabilitation and Water-therapy
- Semmelweis Egyetem Altalanos Orvostudomanyi
- Institue of Endocrinology "C.I Parhon" Bucharest
- Institute of Endocrinology, University Clinical Center
- Fakultna Nemocnica s Poliklinkow Bratislava
- V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Outcomes
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.
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.
Compare plasma concentrations of C2L-OCT-01 PR.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00635765
Brief Title
Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
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 Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ambrilia Biopharma, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
C2L-OCT-01 PR 30 mg
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
Compare plasma concentrations of C2L-OCT-01 PR.
Time Frame
First 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Naudin, M.D.
Organizational Affiliation
Ambrilia Biopharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Republican Centre for Medical Rehabilitation and Water-therapy
City
Minsk
Country
Belarus
Facility Name
Semmelweis Egyetem Altalanos Orvostudomanyi
City
Budapest
Country
Hungary
Facility Name
Institue of Endocrinology "C.I Parhon" Bucharest
City
Bucharest
Country
Romania
Facility Name
Institute of Endocrinology, University Clinical Center
City
Belgrade
Country
Serbia
Facility Name
Fakultna Nemocnica s Poliklinkow Bratislava
City
Bratislava
Country
Slovakia
Facility Name
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
City
Kiev
Country
Ukraine
12. IPD Sharing Statement
Learn more about this trial
Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
We'll reach out to this number within 24 hrs