AcromegalyPhase 3NCT00499993
Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly
A Phase 3 study testing lanreotide (Autogel formulation), duration of treatment 46-48 weeks in people with Acromegaly, run by Ipsen at 24 sites in Italy.
Trial summary
The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly. 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), duration of treatment 46-48 weeks
- How many people
- 63 participants
- Where
- 24 sitesItaly
- Study dates
- Jan 2001to May 2003
- 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
- Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values
Who cannot join
- Patients who have undergone pituitary surgery less than 3 months before selection
- Patients previously treated with radiotherapy
- Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Italy24 sites
Ospedali Riuniti di Bergamo
Bergamo, 24128
Ospedale Maggiore
Bologna, 40133
Clinica Medica - Sezione II Medicina Endocrinologia
Brescia, 25125
Università deglis Studi di Cagliari
Cagliari, 09124
Ospedale Garibaldi
Catania, 95123
Università degli Studi di Ferrara
Ferrara, 44100
Università degli Studi di Firenze
Florence, 50134
D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche
Genova, 16100
Istituto Auxologico
Milan, 20100
Ospedale Maggiore IRCCS
Milan, 20122
Ospedale di Niguarda Cà Granda
Milan, 20162
Università "Federico II" di Napoli
Naples, 80131
Ospedale "S. Luigi Gonzaga"
Orbassano (TO), 10043
Università degli Studi di Padova
Padova, 35128
Azienda Ospedaliera "V. Cervello"
Palermo, 90148
Ospedale Cisanello
Pisa, 56100
Servizio di Endocrinologia
Reggio Emilia, 42100
Università "La Sapienza" di Roma
Roma, 00161
Policlinico Agostino Gemelli
Roma, 00168
Istituto di Patologia Speciale Medica e Metodologia Clinica
Sassari, 07199
Università degli Studi di Ancona, Ospedale Umberto I
Sede Di Torrette (AN) Ancona, 60020
Ospedale Molinette
Torino, 10126
Ospedale Cà Foncello
Treviso, 31100
Ospedale Santa Maria della Misericordia
Udine, 33100
About this study
Official title: Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly
The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.
- Conditions
- Acromegaly
- Being tested
- lanreotide (Autogel formulation), duration of treatment 46-48 weeks
- 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), duration of treatment 46-48 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth hormone assessment
Measured: At every visit
Secondary outcomes (9)
Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments
Measured: At every visit (with the exception of ALS at study inclusion)
Prolactin (PRL) assessment
Measured: At study inclusion, visit 1 and at the final visit of the study
Lanreotide assessment
Measured: At every visit
Clinical symptoms
Measured: At every visit
Quality of life
Measured: At visit 1 and at the final visit of the study
Tumour size
Measured: At inclusion and at the final visit of the study
Evaluation of carotid vessels (on an optional basis)
Measured: At inclusion and at the final visit of the study
Safety assessment evaluated by clinical data
Measured: At every visit
Safety assessment evaluated by laboratory data
Measured: At inclusion visit and at the final visit of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJan 2001
- Study completionMay 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 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
- NCT00499993
- Sponsor's protocol ID
- A-93-52030-077
- Status last verified
- Jan 2019
- First submitted
- 11 Jul 2007
- Last updated
- 15 Jan 2019
- Results posted
- No
Publications
Lombardi G, Minuto F, Tamburrano G, Ambrosio MR, Arnaldi G, Arosio M, Chiarini V, Cozzi R, Grottoli S, Mantero F, Bogazzi F, Terzolo M, Tita P, Boscani PF, Colao A. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. J Endocrinol Invest. 2009 Mar;32(3):202-9. doi: 10.1007/BF03346453.
PubMed 19542735
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly
- ClinicalTrials.gov ID
- NCT00499993
- Acronym / sponsor ID
- A-93-52030-077
- Conditions
- Acromegaly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- May 2003 (actual)
- First posted
- 12 Jul 2007 (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 the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.
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 (1 listed)
- Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values
Key exclusion criteria (3 listed)
- Patients who have undergone pituitary surgery less than 3 months before selection
- Patients previously treated with radiotherapy
- Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months
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), duration of treatment 46-48 weeks | Drug | – |
Primary outcome
Growth hormone assessment
Time frame: At every visit
9 secondary outcomes
Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments
Time frame: At every visit (with the exception of ALS at study inclusion)
Prolactin (PRL) assessment
Time frame: At study inclusion, visit 1 and at the final visit of the study
Lanreotide assessment
Time frame: At every visit
Clinical symptoms
Time frame: At every visit
Quality of life
Time frame: At visit 1 and at the final visit of the study
Tumour size
Time frame: At inclusion and at the final visit of the study
Evaluation of carotid vessels (on an optional basis)
Time frame: At inclusion and at the final visit of the study
Safety assessment evaluated by clinical data
Time frame: At every visit
Safety assessment evaluated by laboratory data
Time frame: At inclusion visit and at the final visit of the study
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 15 Jan 2019.
- Results publication: PubMed 19542735Lombardi G, Minuto F, Tamburrano G, Ambrosio MR, Arnaldi G, Arosio M, Chiarini V, Cozzi R, Grottoli S, Mantero F, Bogazzi F, Terzolo M, Tita P, Boscani PF, Colao A. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. J Endocrinol Invest. 2009 Mar;32(3):202-9. doi: 10.1007/BF03346453.
Related trials for Acromegaly
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RecruitingObservational study
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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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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
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lanreotide (Autogel formulation), duration of treatment 46-48 weeks in people with Acromegaly, run by Ipsen at 24 sites in Italy.
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 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. 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?
Growth hormone assessment (time frame: At every visit). 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 NCT00499993, 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 15 Jan 2019.