NCT00616551

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_3

Geographic Reach
6 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

Enrollment Period

10 months

First QC Date

February 4, 2008

Last Update Submit

October 7, 2008

Conditions

Acromegaly

Keywords

Acromegaly

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    84 days

Study Arms (2)

A

EXPERIMENTAL
Drug: C2L-OCT-01 PR, 30 mg

B

ACTIVE COMPARATOR
Drug: Octreotide acetate prolonged release, 30 mg

Interventions

C2L-OCT-01 PR, 30 mgDRUG

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

A
Octreotide acetate prolonged release, 30 mgDRUG

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

Also known as: Sandostatin LAR, 30 mg
B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Republican Centre for Medical Rehabilitation and Water-therapy

Minsk, Belarus

Location

Semmelweis Egyetem Általános Orvostudományi

Budapest, Hungary

Location

Institute of Endocrinology "C. I. Parhon" Bucharest

Bucharest, Romania

Location

Institute of Endocrinology, University Clinical Center

Belgrade, Serbia

Location

Fakultná Nemocnica s Poliklinkou Bratislava

Bratislava, Slovakia

Location

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

Kiev, Ukraine

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Raphael Naudin, M.D.

    Ambrilia Biopharma, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

April 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

October 8, 2008

Record last verified: 2008-10

Locations

SL(1)RO(1)BE(1)SE(1)HU(1)UA(1)