AcromegalyPhase 3NCT00616551
Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients
A Phase 3 study testing C2L-OCT-01 PR, 30 mg and Octreotide acetate prolonged release, 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 biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients. 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 and Octreotide acetate prolonged release, 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Apr 2007to Feb 2008
- 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
- 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.
Who cannot join
- 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.
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, 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
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.
- Conditions
- Acromegaly
- Being tested
- C2L-OCT-01 PR, 30 mg, Octreotide acetate prolonged release, 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 injection (gluteus) on days 1 and 42
Octreotide acetate prolonged release, 30 mgDrug
Also called Sandostatin LAR, 30 mg
Administered by deep IM (gluteus) on Days 1, 28 and 56
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: C2L-OCT-01 PR, 30 mg |
| B | Active comparator | Not described Receives: Drug: Octreotide acetate prolonged release, 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Days 1, 28, 42, 56 and 84
Secondary outcomes (1)
Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startApr 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
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
- NCT00616551
- Sponsor's protocol ID
- C2L-OCT-01 PR-301
- Status last verified
- Oct 2008
- First submitted
- 4 Feb 2008
- Last updated
- 8 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00616551
- Acronym / sponsor ID
- C2L-OCT-01 PR-301
- Conditions
- Acromegaly
- Keywords
- Acromegaly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ambrilia Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 15 Feb 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 biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat acromegalic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: C2L-OCT-01 PR, 30 mg |
| B | Active comparator | Drug: Octreotide acetate prolonged release, 30 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 injection (gluteus) on days 1 and 42 | Drug | A |
| Octreotide acetate prolonged release, 30 mgAlso: Sandostatin LAR, 30 mgAdministered by deep IM (gluteus) on Days 1, 28 and 56 | Drug | B |
Primary outcome
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
1 secondary outcome
Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR
Time frame: 84 days
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 8 Oct 2008.
Related trials for Acromegaly
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RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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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 and Octreotide acetate prolonged release, 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 7 inclusion and 6 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 8 Oct 2008. 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?
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). 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 8 Oct 2008.