search
Back to results

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

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
C2L-OCT-01 PR, 30 mg
Octreotide acetate prolonged release, 30 mg
Sponsored by
Ambrilia Biopharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Republican Centre for Medical Rehabilitation and Water-therapy
  • Semmelweis Egyetem Általános Orvostudományi
  • Institute of Endocrinology "C. I. Parhon" Bucharest
  • Institute of Endocrinology, University Clinical Center
  • Fakultná Nemocnica s Poliklinkou Bratislava
  • V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

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

Secondary Outcome Measures

Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR

Full Information

First Posted
February 4, 2008
Last Updated
October 7, 2008
Sponsor
Ambrilia Biopharma, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00616551
Brief Title
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

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ambrilia Biopharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
C2L-OCT-01 PR, 30 mg
Intervention Description
Administered by deep IM injection (gluteus) on days 1 and 42
Intervention Type
Drug
Intervention Name(s)
Octreotide acetate prolonged release, 30 mg
Other Intervention Name(s)
Sandostatin LAR, 30 mg
Intervention Description
Administered by deep IM (gluteus) on Days 1, 28 and 56
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Naudin, M.D.
Organizational Affiliation
Ambrilia Biopharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Republican Centre for Medical Rehabilitation and Water-therapy
City
Minsk
Country
Belarus
Facility Name
Semmelweis Egyetem Általános Orvostudományi
City
Budapest
Country
Hungary
Facility Name
Institute of Endocrinology "C. I. Parhon" Bucharest
City
Bucharest
Country
Romania
Facility Name
Institute of Endocrinology, University Clinical Center
City
Belgrade
Country
Serbia
Facility Name
Fakultná Nemocnica s Poliklinkou Bratislava
City
Bratislava
Country
Slovakia
Facility Name
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
City
Kiev
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs