Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients

Overview

The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2008

Interventions

  • Drug: C2L-OCT-01 PR, 30 mg
    • Administered by deep IM injection (gluteus) on days 1 and 42
  • Drug: Octreotide acetate prolonged release, 30 mg
    • Administered by deep IM (gluteus) on Days 1, 28 and 56

Arms, Groups and Cohorts

  • Experimental: A
  • Active Comparator: B

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR
    • Time Frame: 84 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ambrilia Biopharma, Inc.
  • Provider of Information About this Clinical Study
    • Bonabes de Rouge, M.D./Senior Executive Vice-President & Chief Scientist Officer, Ambrilia Biopharma, Inc.
  • Overall Official(s)
    • Raphael Naudin, M.D., Study Director, Ambrilia Biopharma, Inc.

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