AcromegalyPhase 3NCT00635765
Open Label Extension Study Evaluating Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients
A Phase 3 study testing C2L-OCT-01 PR 30 mg in people with Acromegaly, run by Ambrilia Biopharma, Inc. at 6 sites in 6 countries.
Trial summary
The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- C2L-OCT-01 PR 30 mg
- Type of treatment
- Injection or infusion
- How many people
- 63 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Oct 2007to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Subjects who have completed the 24-week C2L-OCT-01 PR-301 study
Who cannot join
- Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating
- Subjects who have experienced any clinically significant adverse event related to study medication in C2L-OCT-01 PR-301 study
- Subjects with uncontrolled Diabetes type II
- Subjects with signs or symptoms related to a tumor compression of the optical chiasm
- Subjects with symptomatic cholelithiasis
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Belarus1 site
Republican Centre for Medical Rehabilitation and Water-therapy
Minsk
Ukraine1 site
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
Kiev
About this study
Official title: Open Label Extension Study Evaluating the Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, Administered Intra Muscularly Every 6, 5 or 4 Weeks in Acromegalic Patients
The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.
- Conditions
- Acromegaly
- Being tested
- C2L-OCT-01 PR 30 mg
- Keywords
- Acromegaly
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2L-OCT-01 PR 30 mgDrug
Administered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study.
Measured: Up to 96 weeks
Secondary outcomes (2)
To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.
Measured: Up to 96 weeks
Compare plasma concentrations of C2L-OCT-01 PR.
Measured: First 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ambrilia Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raphael Naudin, M.D., Study director, Ambrilia Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635765
- Sponsor's protocol ID
- C2L-OCT-01 PR-302
- Status last verified
- Jun 2009
- First submitted
- 11 Mar 2008
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Extension Study Evaluating the Safety and Biological Activity of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, Administered Intra Muscularly Every 6, 5 or 4 Weeks in Acromegalic Patients
- ClinicalTrials.gov ID
- NCT00635765
- Acronym / sponsor ID
- C2L-OCT-01 PR-302
- Conditions
- Acromegaly
- Keywords
- Acromegaly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Ambrilia Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety profile of C2L-OCT-01 PR for up to an additional 96-week period in acromegalic patients who completed the C2L-OCT-01 PR-301 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Subjects who have completed the 24-week C2L-OCT-01 PR-301 study
Key exclusion criteria (5 listed)
- Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating
- Subjects who have experienced any clinically significant adverse event related to study medication in C2L-OCT-01 PR-301 study
- Subjects with uncontrolled Diabetes type II
- Subjects with signs or symptoms related to a tumor compression of the optical chiasm
- Subjects with symptomatic cholelithiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2L-OCT-01 PR 30 mgAdministered by deep IM (gluteus) on Day 1. Beginning on Day 42, drug injection frequency (6, 5 or 4 weeks) and dose modification/adjustment will be allowed for every 3 drug injections based on the mean serum GH and clinical symptoms obtained at the last visit of study C2L-OCT-01 PR-301 and during the course of this study. | Drug | – |
Primary outcome
Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study.
Time frame: Up to 96 weeks
2 secondary outcomes
To determine the percentage of patients who remain with controlled mean GH and normal (gender- and age-matched values) IGF-1 serum concentrations.
Time frame: Up to 96 weeks
Compare plasma concentrations of C2L-OCT-01 PR.
Time frame: First 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael Naudin, M.D. study director
Ambrilia Biopharma, Inc.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing C2L-OCT-01 PR 30 mg in people with Acromegaly, run by Ambrilia Biopharma, Inc. at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belarus, Hungary, Romania, Serbia, Slovakia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess, for up to an additional 96 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6, 5 or 4 weeks in patients who have completed the C2L-OCT-01 PR-301 study. (time frame: Up to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2009.