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

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616551
• Other study ID #: C2L-OCT-01 PR-301
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2008
• Last updated: October 7, 2008
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: October 2008
• Source: Ambrilia Biopharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationRomania: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly

Intervention

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

Locations

Country	Name	City	State
Belarus	Republican Centre for Medical Rehabilitation and Water-therapy	Minsk
Hungary	Semmelweis Egyetem Általános Orvostudományi	Budapest
Romania	Institute of Endocrinology "C. I. Parhon" Bucharest	Bucharest
Serbia	Institute of Endocrinology, University Clinical Center	Belgrade
Slovakia	Fakultná Nemocnica s Poliklinkou Bratislava	Bratislava
Ukraine	V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Ambrilia Biopharma, Inc.

Countries where clinical trial is conducted

Belarus,  Hungary,  Romania,  Serbia,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Days 1, 28, 42, 56 and 84	Yes
Secondary	Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR		84 days	Yes