AcromegalyPhase 2/3NCT00234572
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
A Phase 2/3 study testing Lanreotide (Autogel formulation) in people with Acromegaly, run by Ipsen at 29 sites in 8 countries.
Trial summary
The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses. 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
- 108 participants
- Where
- 29 sitesin 8 countries
- Study dates
- May 2000to 3 Jan 2003
- Phase
- Phase 2/3
- 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
- documentation of a diagnosis of active acromegaly based on either of the following definitions:
- the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level >5ng/mL at visit 1; or
- the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH >3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a)
Who cannot join
- receipt of radiotherapy for acromegaly within 3 years
- pituitary surgery within 3 months prior to visit 1
- prior receipt of lanreotide autogel or GH antagonist
- anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period
- known hypersensitivity to any of the test materials or related compounds
- clinically significant renal or hepatic abnormalities
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
United States11 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Baptist Health System Inc
Birmingham, Alabama, 35213
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern Medical Facility
Chicago, Illinois, 60611
University of Cincinnati
Cincinnati, Ohio, 45267
Ben Taub Hospital
Houston, Texas, 77030
Pituitary Center
Los Angeles, California, 90048
New York University Medical Center
New York, New York, 10010
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health Sciences University
Portland, Oregon, 97201
France4 sites
Clinique Marc Linquette
Lille, 59037
Hôpital Lariboisière - Service de Médecine B
Paris, 75010
Hôpital Cochin - Service d'Endocrinologie
Paris, 75014
CHRU de Brabois
Vandœuvre-lès-Nancy, 54511
Czechia3 sites
St Ann's Faculty Hospital
Brno
University Hospital Charles University
Hradec Králové, 500 05
Charles University
Prague, 120 00
Germany3 sites
Universitätklinikum Charité
Berlin, 10117
Med. Klinik der Universitätat Essen
Essen, 45147
Medizinische Klinik Innenstadt
München, 80336
United Kingdom3 sites
Queen Elizabeth Hospital
Edgbaston, Birmingham, B15 2TH
The Royal Free Hospital
Hampstead, London, NW3 2QG
Christie Hospital
Manchester, M204BX
Hungary2 sites
Semmelweiss University Medical School
Budapest, 1088
Semmelweiss University
Budapest, 1135
Netherlands2 sites
Academic Hospital Leiden
Leiden, 2300
Academic Hospital Rotterdam
Rotterdam, 3000
About this study
Official title: Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.
The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.
- 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.
Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Secondary outcomes (1)
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startMay 2000
- Primary completion3 Jan 2003
- Study completion3 Jan 2003
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 108 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
- NCT00234572
- Sponsor's protocol ID
- E-28-52030-717
- Status last verified
- Aug 2019
- First submitted
- 6 Oct 2005
- Last updated
- 2 Aug 2019
- Results posted
- No
Publications
Melmed S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13(1):18-28. doi: 10.1007/s11102-009-0191-1. Epub 2009 Jul 29.
PubMed 19639415
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.
- ClinicalTrials.gov ID
- NCT00234572
- Acronym / sponsor ID
- E-28-52030-717
- Conditions
- Acromegaly
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- 3 Jan 2003 (actual)
- Study completion
- 3 Jan 2003 (actual)
- First posted
- 7 Oct 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 compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- documentation of a diagnosis of active acromegaly based on either of the following definitions:
Key exclusion criteria (6 listed)
- receipt of radiotherapy for acromegaly within 3 years
- pituitary surgery within 3 months prior to visit 1
- prior receipt of lanreotide autogel or GH antagonist
- anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period
- known hypersensitivity to any of the test materials or related compounds
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
Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
1 secondary outcome
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
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 2 Aug 2019.
- Results publication: PubMed 19639415Melmed S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13(1):18-28. doi: 10.1007/s11102-009-0191-1. Epub 2009 Jul 29.
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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
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lanreotide (Autogel formulation) in people with Acromegaly, run by Ipsen at 29 sites in 8 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 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 2 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 29 sites in United States, France, Czechia, Germany, United Kingdom and 3 more countries. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal. 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 NCT00234572, 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 2 Aug 2019.