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

This study has been completed.
Sponsor:
Information provided by:
Ambrilia Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT00616551
First received: February 4, 2008
Last updated: October 7, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: C2L-OCT-01 PR, 30 mg
Drug: Octreotide acetate prolonged release, 30 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ambrilia Biopharma, Inc.:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: April 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: C2L-OCT-01 PR, 30 mg
Administered by deep IM injection (gluteus) on days 1 and 42
Active Comparator: B Drug: Octreotide acetate prolonged release, 30 mg
Administered by deep IM (gluteus) on Days 1, 28 and 56
Other Name: Sandostatin LAR, 30 mg

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616551

Locations
Belarus
Republican Centre for Medical Rehabilitation and Water-therapy
Minsk, Belarus
Hungary
Semmelweis Egyetem Általános Orvostudományi
Budapest, Hungary
Romania
Institute of Endocrinology "C. I. Parhon" Bucharest
Bucharest, Romania
Serbia
Institute of Endocrinology, University Clinical Center
Belgrade, Serbia
Slovakia
Fakultná Nemocnica s Poliklinkou 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: NCT00616551     History of Changes
Other Study ID Numbers: C2L-OCT-01 PR-301
Study First Received: February 4, 2008
Last Updated: October 7, 2008
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
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014