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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: |
NCT00616551 |
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Date of registration:
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04/02/2008 |
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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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Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients
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Scientific title:
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Open Label, Randomized Study Comparing the Biological Efficacy & Safety of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, 30 mg Administered Every 42 Days for 84 Days With Sandostatin LAR 30 mg Administered Every 28 Days for 84 Days to Acromegalic Patients |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00616551 |
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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/Efficacy Study, Intervention Model: Parallel 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:
- Subject must be diagnosed with active acromegaly.
- If subject is treated with a long acting somatostatin analogue, the treatment must
have been unchanged for a period of at least 12 weeks prior to entry.
- If subject is treated with a 30 mg dose of a depot formulation of a somatostatin
analogue, the IGF-1 levels must be normal at entry.
- If subject is treated with a 20 mg dose of a depot formulation of a somatostatin
analogue, any value of IGF-1 is acceptable.
- If the subject is receiving an immediate release formulation of a somatostatin
analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference
range based on gender and age.
- If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to
receiving the study medication.
- The subject should be able to understand the instructions, provide a written consent
and abide by the study restrictions.
Exclusion Criteria:
- Women of childbearing potential who are not taking adequate contraception or who are
pregnant or lactating.
- Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant)
within 12 weeks of study entry.
- Subjects who have undergone pituitary surgery within 6 months or radiotherapy within
2 years prior to admission into the study
- Subjects who present some form of intolerance or allergy to the test article or one
of its non-active ingredients
- Subject who have any other condition that alters the growth hormone or IGF-1 levels.
- Subjects with signs or symptoms related to a tumor compression of the optical chiasm.
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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Drug: Octreotide acetate prolonged release, 30 mg
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Primary Outcome(s)
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Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg
[Time Frame: Days 1, 28, 42, 56 and 84]
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Secondary Outcome(s)
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Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR
[Time Frame: 84 days]
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Secondary ID(s)
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C2L-OCT-01 PR-301
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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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