AcromegalyPhase 4NCT00216398
Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR
A Phase 4 study testing Lanreotide (Autogel formulation) in people with Acromegaly, run by Ipsen at 1 site in Australia.
Trial summary
The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Lanreotide (Autogel formulation)
- How many people
- 8 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2004to 22 Jun 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acromegaly
- The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
- The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
- Life expectancy of at least 2 years
Who cannot join
- Adenectomy within past 6 months, or likely during study period
- Radiotherapy for acromegalic disease within 1 year, or likely during study period
- Unstable concomitant dopamine agonist therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR
The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.
- Conditions
- Acromegaly
- Being tested
- Lanreotide (Autogel formulation)
- Keywords
- acromegaly, growth hormone
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide (Autogel formulation)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
Secondary outcomes (8)
The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
The percentage of patients with normalised IGF-1 compared to the baseline visit.
Change in the GH values compared to the baseline (Week 0) visit.
Change in the IGF-1 values compared to the baseline (Week 0) visit.
Change in serum lanreotide levels compared to the baseline (Week 0) visit.
Change in the serum octreotide levels compared to the baseline visit.
Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2004
- Primary completion22 Jun 2006
- Study completion22 Jun 2006
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.
- More trials run by IpsenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Study Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216398
- Sponsor's protocol ID
- A-9B-52030-159
- Status last verified
- Aug 2019
- First submitted
- 13 Sep 2005
- Last updated
- 16 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR
- ClinicalTrials.gov ID
- NCT00216398
- Acronym / sponsor ID
- A-9B-52030-159
- Conditions
- Acromegaly
- Keywords
- acromegaly, growth hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- 22 Jun 2006 (actual)
- Study completion
- 22 Jun 2006 (actual)
- First posted
- 22 Sep 2005 (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 efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of acromegaly
- The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
- The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
- Life expectancy of at least 2 years
Key exclusion criteria (3 listed)
- Adenectomy within past 6 months, or likely during study period
- Radiotherapy for acromegalic disease within 1 year, or likely during study period
- Unstable concomitant dopamine agonist therapy
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 |
|---|---|---|
| Lanreotide (Autogel formulation) | Drug | – |
Primary outcome
The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.
8 secondary outcomes
The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
The percentage of patients with normalised IGF-1 compared to the baseline visit.
Change in the GH values compared to the baseline (Week 0) visit.
Change in the IGF-1 values compared to the baseline (Week 0) visit.
Change in serum lanreotide levels compared to the baseline (Week 0) visit.
Change in the serum octreotide levels compared to the baseline visit.
Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
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 16 Aug 2019.
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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.
Ipsen Study Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lanreotide (Autogel formulation) in people with Acromegaly, run by Ipsen at 1 site in Australia.
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 4 inclusion and 3 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 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.. 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 16 Aug 2019.