AcromegalyPhase 4ATG1lineNCT00627796
Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly
A Phase 4 study testing Lanreotide-Autogel 120 mg in people with Acromegaly, run by Federico II University at 1 site in Italy.
Trial summary
Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- Lanreotide-Autogel 120 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2003to Dec 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active acromegaly [serum GH levels above 2.5 μg/liter and/or above 1 μg/liter after oral glucose tolerance test (OGTT) and abnormal IGF-I values] with a micro- (<10 mm max tumor diameter) or macroadenoma (>10 mm max tumor diameter)
- Patients never treated before
- Patients who do not require immediate surgery because of neurological symptoms and/or emergency conditions
- Patients who signed an informed consent to participate to the study.
Who cannot join
- Patients already treated before with surgery or radiotherapy or with medical treatment
- Patients with mixed GH-PRL adenomas who require combined somatostatin and dopamine treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open, Prospective, Observational Study to Investigate the Effect of Lanreotide Autogel 120 mg on Control of GH and IGF-I Excess and Tumor Shrinkage in Newly Diagnosed Patients With Acromegaly
Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7).
Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10).
The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
Read the detailed description
This is an open, prospective, observational, clinical study to be performed in two University Hospitals (Naples and Genova, Italy). The primary objective is to evaluate the efficacy of the ATG 120 mg on control of GH and IGF-I excess in acromegaly according with the currently accepted criteria (12) and on tumor shrinkage. The secondary objectives are to assess improvement of clinical symptoms and safety profile. The study population will consist of at least 20 patients, enrolled in the two centers from Jan 1st 2003 to June 30th 2007. Patients give their written informed consent prior to entering into the study. The study was performed according to the principles defined by the declaration The safety population, as defined by the protocol, consists of patients who received at least one study drug dosing.
Hormonal evaluation GH levels are assessed as a mean value of 5 samples at 30-min intervals (starting between 08:00 and 9:00 in the morning) taken at each visit before the injection of ATG. IGF-I levels are assessed as a single sample taken at each visit at the same time as the first GH sample. All hormonal parameters were assessed in a central laboratory (University of Genoa).
Improvement in clinical symptoms is considered on the basis of a semiquantitative scale for asthenia, hyperhidrosis, headache, swelling of extremities, arthralgia, paraesthesia, carpal tunnel syndrome: symptoms were graded as 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
Any adverse event (AE) during the study is monitored and reported by the investigators. Safety, evaluated by local laboratory data, is assessed at inclusion and at the final visit by: hematology: erythrocytes, leukocytes, platelets, haemoglobin, hematocrit; biochemistry: glucose, creatinine, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), electrolytes (sodium, potassium, calcium, phosphorous) glycosylated haemoglobin, triglycerides, total and high density lipoproteins (HDL) cholesterol, blood amylase, iron, transferrin, prothrombin; glucose and insulin concentrations; hormonal evaluation: thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free triiodothyronine (FT4), follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels. Safety related to gallbladder is assessed by ultrasound examination performed at inclusion and at the end of the study.
- Conditions
- Acromegaly
- Being tested
- Lanreotide-Autogel 120 mg
- Keywords
- GH, IGF-I, tumor, lanreotide
- Medical subject headings
- Acromegaly, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide-Autogel 120 mgDrug
Also called Ipstyl
ATG120 mg is given as deep subcutaneous injection into the buttock. Each patient receives one deep subcutaneous injection of ATG120 mg at Visit 1 (V1) and subsequent injection every 4 weeks for 3 injections. Based on GH levels, the dosing interval has been determined as follows: if GH levels were > 2.5 mcg/l, ATG 120 mg is given every 4 weeks while if they were < 2.5 mcg/l ATG 120 mg is administered every 6 weeks for another 3 injections. Afterwards, the dose is maintained as above except in patients with GH levels <1 mcg/l receiving ATG 120 mg every 8 weeks. The estimated duration of treatment is 48-52 weeks according with dose titration.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Newly diagnosed patients with acromegaly Receives: Drug: Lanreotide-Autogel 120 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of GH and IGF-I excess and tumor shrinkage
Measured: 3 and 12 months
Secondary outcomes (1)
Improvement of clinical symptoms and safety profile
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJan 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Genova
- Investigators
- Annamaria Colao, MD, PhD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627796
- Sponsor's protocol ID
- NeuroendoUnit-9
- Acronym
- ATG1line
- Status last verified
- Dec 2007
- First submitted
- 22 Feb 2008
- Last updated
- 3 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Antonijoan RM, Barbanoj MJ, Cordero JA, Peraire C, Obach R, Valles J, Cherif-Cheikh R, Torres ML, Bismuth F, Montes M. Pharmacokinetics of a new Autogel formulation of the somatostatin analogue lanreotide after a single subcutaneous dose in healthy volunteers. J Pharm Pharmacol. 2004 Apr;56(4):471-6. doi: 10.1211/0022357023123.
PubMed 15099442Caron P, Beckers A, Cullen DR, Goth MI, Gutt B, Laurberg P, Pico AM, Valimaki M, Zgliczynski W. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegaly. J Clin Endocrinol Metab. 2002 Jan;87(1):99-104. doi: 10.1210/jcem.87.1.8153.
PubMed 11788630Lucas T, Astorga R; Spanish-Portuguese Multicentre Autogel Study Group on Acromegaly. Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial. Clin Endocrinol (Oxf). 2006 Sep;65(3):320-6. doi: 10.1111/j.1365-2265.2006.02595.x.
PubMed 16918950Ashwell SG, Bevan JS, Edwards OM, Harris MM, Holmes C, Middleton MA, James RA. The efficacy and safety of lanreotide Autogel in patients with acromegaly previously treated with octreotide LAR. Eur J Endocrinol. 2004 Apr;150(4):473-80. doi: 10.1530/eje.0.1500473.
PubMed 15080776Alexopoulou O, Abrams P, Verhelst J, Poppe K, Velkeniers B, Abs R, Maiter D. Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR. Eur J Endocrinol. 2004 Sep;151(3):317-24. doi: 10.1530/eje.0.1510317.
PubMed 15362960van Thiel SW, Romijn JA, Biermasz NR, Ballieux BE, Frolich M, Smit JW, Corssmit EP, Roelfsema F, Pereira AM. Octreotide long-acting repeatable and lanreotide Autogel are equally effective in controlling growth hormone secretion in acromegalic patients. Eur J Endocrinol. 2004 Apr;150(4):489-95. doi: 10.1530/eje.0.1500489.
PubMed 15080778Ronchi CL, Boschetti M, Degli Uberti EC, Mariotti S, Grottoli S, Loli P, Lombardi G, Tamburrano G, Arvigo M, Angeletti G, Boscani PF, Beck-Peccoz P, Arosio M; Italian Multicenter Autogel Study Group in Acromegaly. Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study. Clin Endocrinol (Oxf). 2007 Oct;67(4):512-9. doi: 10.1111/j.1365-2265.2007.02917.x. Epub 2007 Jun 7.
PubMed 17555511Colao A, Martino E, Cappabianca P, Cozzi R, Scanarini M, Ghigo E; A.L.I.C.E. Study Group. First-line therapy of acromegaly: a statement of the A.L.I.C.E. (Acromegaly primary medical treatment Learning and Improvement with Continuous Medical Education) Study Group. J Endocrinol Invest. 2006 Dec;29(11):1017-20. doi: 10.1007/BF03349217. No abstract available.
PubMed 17259801Bevan JS. Clinical review: The antitumoral effects of somatostatin analog therapy in acromegaly. J Clin Endocrinol Metab. 2005 Mar;90(3):1856-63. doi: 10.1210/jc.2004-1093. Epub 2004 Dec 21.
PubMed 15613435Melmed S, Sternberg R, Cook D, Klibanski A, Chanson P, Bonert V, Vance ML, Rhew D, Kleinberg D, Barkan A. A critical analysis of pituitary tumor shrinkage during primary medical therapy in acromegaly. J Clin Endocrinol Metab. 2005 Jul;90(7):4405-10. doi: 10.1210/jc.2004-2466. Epub 2005 Apr 12.
PubMed 15827109Colao A, Auriemma RS, Rebora A, Galdiero M, Resmini E, Minuto F, Lombardi G, Pivonello R, Ferone D. Significant tumour shrinkage after 12 months of lanreotide Autogel-120 mg treatment given first-line in acromegaly. Clin Endocrinol (Oxf). 2009 Aug;71(2):237-45. doi: 10.1111/j.1365-2265.2008.03503.x. Epub 2008 Dec 15.
PubMed 19094074
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Prospective, Observational Study to Investigate the Effect of Lanreotide Autogel 120 mg on Control of GH and IGF-I Excess and Tumor Shrinkage in Newly Diagnosed Patients With Acromegaly
- ClinicalTrials.gov ID
- NCT00627796
- Acronym / sponsor ID
- ATG1line / NeuroendoUnit-9
- Conditions
- Acromegaly
- Keywords
- GH, IGF-I, tumor, lanreotide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- University of Genova
- Study start
- Jan 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Mar 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.
Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7).
Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10).
The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
Detailed description
This is an open, prospective, observational, clinical study to be performed in two University Hospitals (Naples and Genova, Italy). The primary objective is to evaluate the efficacy of the ATG 120 mg on control of GH and IGF-I excess in acromegaly according with the currently accepted criteria (12) and on tumor shrinkage. The secondary objectives are to assess improvement of clinical symptoms and safety profile. The study population will consist of at least 20 patients, enrolled in the two centers from Jan 1st 2003 to June 30th 2007. Patients give their written informed consent prior to entering into the study. The study was performed according to the principles defined by the declaration The safety population, as defined by the protocol, consists of patients who received at least one study drug dosing.
Hormonal evaluation GH levels are assessed as a mean value of 5 samples at 30-min intervals (starting between 08:00 and 9:00 in the morning) taken at each visit before the injection of ATG. IGF-I levels are assessed as a single sample taken at each visit at the same time as the first GH sample. All hormonal parameters were assessed in a central laboratory (University of Genoa).
Improvement in clinical symptoms is considered on the basis of a semiquantitative scale for asthenia, hyperhidrosis, headache, swelling of extremities, arthralgia, paraesthesia, carpal tunnel syndrome: symptoms were graded as 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
Any adverse event (AE) during the study is monitored and reported by the investigators. Safety, evaluated by local laboratory data, is assessed at inclusion and at the final visit by: hematology: erythrocytes, leukocytes, platelets, haemoglobin, hematocrit; biochemistry: glucose, creatinine, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), electrolytes (sodium, potassium, calcium, phosphorous) glycosylated haemoglobin, triglycerides, total and high density lipoproteins (HDL) cholesterol, blood amylase, iron, transferrin, prothrombin; glucose and insulin concentrations; hormonal evaluation: thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free triiodothyronine (FT4), follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels. Safety related to gallbladder is assessed by ultrasound examination performed at inclusion and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Lanreotide-Autogel 120 mgNewly diagnosed patients with acromegaly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with active acromegaly [serum GH levels above 2.5 μg/liter and/or above 1 μg/liter after oral glucose tolerance test (OGTT) and abnormal IGF-I values] with a micro- (<10 mm max tumor diameter) or macroadenoma (>10 mm max tumor diameter)
- Patients never treated before
- Patients who do not require immediate surgery because of neurological symptoms and/or emergency conditions
- Patients who signed an informed consent to participate to the study.
Key exclusion criteria (2 listed)
- Patients already treated before with surgery or radiotherapy or with medical treatment
- Patients with mixed GH-PRL adenomas who require combined somatostatin and dopamine treatment
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 120 mgAlso: IpstylATG120 mg is given as deep subcutaneous injection into the buttock. Each patient receives one deep subcutaneous injection of ATG120 mg at Visit 1 (V1) and subsequent injection every 4 weeks for 3 injections. Based on GH levels, the dosing interval has been determined as follows: if GH levels were > 2.5 mcg/l, ATG 120 mg is given every 4 weeks while if they were < 2.5 mcg/l ATG 120 mg is administered every 6 weeks for another 3 injections. Afterwards, the dose is maintained as above except in patients with GH levels <1 mcg/l receiving ATG 120 mg every 8 weeks. The estimated duration of treatment is 48-52 weeks according with dose titration. | Drug | A |
Primary outcome
Control of GH and IGF-I excess and tumor shrinkage
Time frame: 3 and 12 months
1 secondary outcome
Improvement of clinical symptoms and safety profile
Time frame: 3 and 12 months
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 3 Mar 2008.
- Results publication: PubMed 15099442Antonijoan RM, Barbanoj MJ, Cordero JA, Peraire C, Obach R, Valles J, Cherif-Cheikh R, Torres ML, Bismuth F, Montes M. Pharmacokinetics of a new Autogel formulation of the somatostatin analogue lanreotide after a single subcutaneous dose in healthy volunteers. J Pharm Pharmacol. 2004 Apr;56(4):471-6. doi: 10.1211/0022357023123.
- Results publication: PubMed 11788630Caron P, Beckers A, Cullen DR, Goth MI, Gutt B, Laurberg P, Pico AM, Valimaki M, Zgliczynski W. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in the management of acromegaly. J Clin Endocrinol Metab. 2002 Jan;87(1):99-104. doi: 10.1210/jcem.87.1.8153.
- Results publication: PubMed 16918950Lucas T, Astorga R; Spanish-Portuguese Multicentre Autogel Study Group on Acromegaly. Efficacy of lanreotide Autogel administered every 4-8 weeks in patients with acromegaly previously responsive to lanreotide microparticles 30 mg: a phase III trial. Clin Endocrinol (Oxf). 2006 Sep;65(3):320-6. doi: 10.1111/j.1365-2265.2006.02595.x.
- Results publication: PubMed 15080776Ashwell SG, Bevan JS, Edwards OM, Harris MM, Holmes C, Middleton MA, James RA. The efficacy and safety of lanreotide Autogel in patients with acromegaly previously treated with octreotide LAR. Eur J Endocrinol. 2004 Apr;150(4):473-80. doi: 10.1530/eje.0.1500473.
- Results publication: PubMed 15362960Alexopoulou O, Abrams P, Verhelst J, Poppe K, Velkeniers B, Abs R, Maiter D. Efficacy and tolerability of lanreotide Autogel therapy in acromegalic patients previously treated with octreotide LAR. Eur J Endocrinol. 2004 Sep;151(3):317-24. doi: 10.1530/eje.0.1510317.
- Results publication: PubMed 15080778van Thiel SW, Romijn JA, Biermasz NR, Ballieux BE, Frolich M, Smit JW, Corssmit EP, Roelfsema F, Pereira AM. Octreotide long-acting repeatable and lanreotide Autogel are equally effective in controlling growth hormone secretion in acromegalic patients. Eur J Endocrinol. 2004 Apr;150(4):489-95. doi: 10.1530/eje.0.1500489.
- Results publication: PubMed 17555511Ronchi CL, Boschetti M, Degli Uberti EC, Mariotti S, Grottoli S, Loli P, Lombardi G, Tamburrano G, Arvigo M, Angeletti G, Boscani PF, Beck-Peccoz P, Arosio M; Italian Multicenter Autogel Study Group in Acromegaly. Efficacy of a slow-release formulation of lanreotide (Autogel) 120 mg) in patients with acromegaly previously treated with octreotide long acting release (LAR): an open, multicentre longitudinal study. Clin Endocrinol (Oxf). 2007 Oct;67(4):512-9. doi: 10.1111/j.1365-2265.2007.02917.x. Epub 2007 Jun 7.
- Results publication: PubMed 17259801Colao A, Martino E, Cappabianca P, Cozzi R, Scanarini M, Ghigo E; A.L.I.C.E. Study Group. First-line therapy of acromegaly: a statement of the A.L.I.C.E. (Acromegaly primary medical treatment Learning and Improvement with Continuous Medical Education) Study Group. J Endocrinol Invest. 2006 Dec;29(11):1017-20. doi: 10.1007/BF03349217. No abstract available.
- Results publication: PubMed 15613435Bevan JS. Clinical review: The antitumoral effects of somatostatin analog therapy in acromegaly. J Clin Endocrinol Metab. 2005 Mar;90(3):1856-63. doi: 10.1210/jc.2004-1093. Epub 2004 Dec 21.
- Results publication: PubMed 15827109Melmed S, Sternberg R, Cook D, Klibanski A, Chanson P, Bonert V, Vance ML, Rhew D, Kleinberg D, Barkan A. A critical analysis of pituitary tumor shrinkage during primary medical therapy in acromegaly. J Clin Endocrinol Metab. 2005 Jul;90(7):4405-10. doi: 10.1210/jc.2004-2466. Epub 2005 Apr 12.
- Derived from this study: PubMed 19094074Colao A, Auriemma RS, Rebora A, Galdiero M, Resmini E, Minuto F, Lombardi G, Pivonello R, Ferone D. Significant tumour shrinkage after 12 months of lanreotide Autogel-120 mg treatment given first-line in acromegaly. Clin Endocrinol (Oxf). 2009 Aug;71(2):237-45. doi: 10.1111/j.1365-2265.2008.03503.x. Epub 2008 Dec 15.
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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.
Annamaria Colao, MD, PhD principal investigator
Federico II University
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 120 mg in people with Acromegaly, run by Federico II University at 1 site 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 4 inclusion and 2 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 3 Mar 2008. 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 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 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?
Control of GH and IGF-I excess and tumor shrinkage (time frame: 3 and 12 months). 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 NCT00627796, which also lists 11 linked publications.
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 3 Mar 2008.