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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00616551
Other study ID # C2L-OCT-01 PR-301
Secondary ID
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


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
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Active, not recruiting NCT03252353 - Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly Phase 3