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

NCT ID: NCT00616551

Last Updated: 2008-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Acromegaly

Keywords

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Acromegaly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

C2L-OCT-01 PR, 30 mg

Intervention Type DRUG

Administered by deep IM injection (gluteus) on days 1 and 42

B

Group Type ACTIVE_COMPARATOR

Octreotide acetate prolonged release, 30 mg

Intervention Type DRUG

Administered by deep IM (gluteus) on Days 1, 28 and 56

Interventions

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C2L-OCT-01 PR, 30 mg

Administered by deep IM injection (gluteus) on days 1 and 42

Intervention Type DRUG

Octreotide acetate prolonged release, 30 mg

Administered by deep IM (gluteus) on Days 1, 28 and 56

Intervention Type DRUG

Other Intervention Names

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Sandostatin LAR, 30 mg

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ambrilia Biopharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Ambrilia Biopharma, Inc.

Principal Investigators

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Raphael Naudin, M.D.

Role: STUDY_DIRECTOR

Ambrilia Biopharma, Inc.

Locations

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Republican Centre for Medical Rehabilitation and Water-therapy

Minsk, , Belarus

Site Status

Semmelweis Egyetem Általános Orvostudományi

Budapest, , Hungary

Site Status

Institute of Endocrinology "C. I. Parhon" Bucharest

Bucharest, , Romania

Site Status

Institute of Endocrinology, University Clinical Center

Belgrade, , Serbia

Site Status

Fakultná Nemocnica s Poliklinkou Bratislava

Bratislava, , Slovakia

Site Status

V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine

Kiev, , Ukraine

Site Status

Countries

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Serbia and Montenegro Belarus Hungary Romania Serbia Slovakia Ukraine

Other Identifiers

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C2L-OCT-01 PR-301

Identifier Type: -

Identifier Source: org_study_id