Clinical trial NCT00616551: Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Keywords: Acromegaly
Lead sponsor: Ambrilia Biopharma, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Days 1, 28, 42, 56 and 84
Secondary outcomes:
measure: Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR
timeFrame: 84 days
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Republican Centre for Medical Rehabilitation and Water-therapy
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Általános Orvostudományi
city: Bucharest
country: Romania
facility: Institute of Endocrinology "C. I. Parhon" Bucharest
city: Belgrade
country: Serbia
facility: Institute of Endocrinology, University Clinical Center
city: Bratislava
country: Slovakia
facility: Fakultná Nemocnica s Poliklinkou Bratislava
city: Kiev
country: Ukraine
facility: V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Study officials:
affiliation: Ambrilia Biopharma, Inc.
name: Raphael Naudin, M.D.
role: STUDY_DIRECTOR
References: