AcromegalyPhase 3NCT00210457
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients
A Phase 3 study testing Lanreotide (Autogel formulation) in people with Acromegaly, run by Ipsen at 17 sites in 2 countries.
Trial summary
To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues. 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
- 63 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Sep 2000to 15 Jul 2002
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:
- patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range,
- patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range.
Who cannot join
- Patient having had pituitary surgery within the previous 3 months
- Patient having received radiotherapy for acromegaly disease within the previous 36 months
- Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period
- Patient having received lanreotide autogel at any time before the study
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
France16 sites
Hôpital Sud
Amiens, 80054
Chu d'Angers
Angers, 49033
Hôpital de Bois Guillaume
Bois-Guillaume, 76233
Chu de la Cote de Nacre
Caen, 14033
Hôpital du Bocage
Dijon, 21034
Chu de Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital du Cluzeau
Limoges, 87042
Hôpital Neurologique
Lyon, 69394
Hôpital Lapeyronie
Montpellier, 34059
Hôpital de l'Archet 1
Nice, 06202
Hôpital du Haut-Levêque
Pessac, 33604
Hôpital Maison Blanche
Reims, 51092
Hôpital Sud
Rennes, 35056
Hôpital Bellevue
Saint-Etienne, 42055
Hôpital de Hautepierre
Strasbourg, 67098
Hôpital de Rangueil
Toulouse, 31403
About this study
Official title: Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.
To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.
- Conditions
- Acromegaly
- Being tested
- Lanreotide (Autogel formulation)
- 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.
Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)
Secondary outcomes (6)
Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Mean growth hormone (GH) levels
Number of patients having a serum GH level at or below 2.5ng/ml
Number of patients having a serum GH level at or below 1 ng/ml
Number of patients with no or reduced clinical signs of acromegaly
Long-term safety of repeated injections of lanreotide autogel at titrated doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2000
- Primary completion15 Jul 2002
- Study completion15 Jul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210457
- Sponsor's protocol ID
- E-54-52030-081
- Status last verified
- Mar 2020
- First submitted
- 19 Sep 2005
- Last updated
- 31 Mar 2020
- Results posted
- No
Publications
Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B; Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008 Aug;69(2):299-305. doi: 10.1111/j.1365-2265.2008.03208.x. Epub 2008 Jan 31.
PubMed 18248639
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.
- ClinicalTrials.gov ID
- NCT00210457
- Acronym / sponsor ID
- E-54-52030-081
- Conditions
- Acromegaly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- 15 Jul 2002 (actual)
- Study completion
- 15 Jul 2002 (actual)
- First posted
- 21 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.
To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.
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 (3 listed)
- Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:
Key exclusion criteria (4 listed)
- Patient having had pituitary surgery within the previous 3 months
- Patient having received radiotherapy for acromegaly disease within the previous 36 months
- Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period
- Patient having received lanreotide autogel at any time before the study
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
Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)
6 secondary outcomes
Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range
Mean growth hormone (GH) levels
Number of patients having a serum GH level at or below 2.5ng/ml
Number of patients having a serum GH level at or below 1 ng/ml
Number of patients with no or reduced clinical signs of acromegaly
Long-term safety of repeated injections of lanreotide autogel at titrated doses
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 31 Mar 2020.
- Results publication: PubMed 18248639Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B; Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008 Aug;69(2):299-305. doi: 10.1111/j.1365-2265.2008.03208.x. Epub 2008 Jan 31.
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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 Medical Director study director
Ipsen
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lanreotide (Autogel formulation) in people with Acromegaly, run by Ipsen at 17 sites in 2 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 3 inclusion and 4 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Switzerland. 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?
Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00210457, which also lists 1 linked publication.
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 31 Mar 2020.