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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00635765 |
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Date of registration:
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11/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
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Scientific title:
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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 |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00635765 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belarus
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Former Serbia and Montenegro
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Hungary
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Romania
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Serbia
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Slovakia
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Ukraine
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Contacts
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Name:
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Raphael Naudin, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ambrilia Biopharma, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acromegaly
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Intervention(s)
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Drug: C2L-OCT-01 PR 30 mg
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Compare plasma concentrations of C2L-OCT-01 PR.
[Time Frame: First 6 months]
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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]
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Secondary ID(s)
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C2L-OCT-01 PR-302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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