AcromegalyPhase 4HDacroNCT00461149
Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly
A Phase 4 study testing Octreotide-LAR in people with Acromegaly, run by Federico II University at 1 site in Italy.
Trial summary
Epidemiological data indicate that patients with active acromegaly have reduced life expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A post-treatment GH value <5 mU/liter (equal to <2.5 μg/liter) and IGF-I in the normal range for age are recognized as the most predictive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Octreotide-LAR
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1995to Dec 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
- patients with newly diagnosed acromegaly
- age above 18 years
- no previous treatments for acromegaly
Who cannot join
- primary surgery
- concomitant hyperprolactinemia if requiring combined treatment with dopamine-agonist
- primary treatment with lanreotide
- treatment duration less than 24 months
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Molecular and Clinical Endocrinology and Oncology University Federico II of Naples
Naples, 80131
About this study
Official title: Beneficial Effect of Dose Escalation of Octreotide-LAR as First-Line Therapy in Patients With Resistant Acromegaly
Epidemiological data indicate that patients with active acromegaly have reduced life expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A post-treatment GH value <5 mU/liter (equal to <2.5 μg/liter) and IGF-I in the normal range for age are recognized as the most predictive survival indices.
Since their introduction into clinical use approximately two decades ago, somatostatin analogs have been considered a cornerstone of medical therapy for acromegaly. After 12 months of treatment with octreotide-LAR, control of GH and IGF-I excess, is achieved in 54% and 63% of unselected patients (11). The proportion of subjects achieving IGF-I normalization increases significantly with time (12). Significant tumor shrinkage has also been reported in a number of studies (13,14): an average 50% tumor decrease is achieved when the drug is used exclusively, or before surgery or radiotherapy (14). In 99 unselected newly diagnosed patients after 12 months of treatment with somatostatin analogues we reported control of GH levels in 57.6% and IGF-I levels in 45.5% and a greater than 50% tumor shrinkage in 44.4% (15).
Read more
The dose of LAR in different studies ranged from 10-40 mg every 28 days (q28d): high doses are generally administered in patients who do not control GH and IGF-I excess with lower doses. As reported in the meta-analysis (11) the rate of IGF-I normalization tended to be lower as octreotide-LAR dose was raised: 90% in patients treated with 10 mg, 61% with 20 mg and 53% with 30 mg. However, some further benefit by increasing the dose of octreotide-LAR was reported in some studies (16-18).
Data on dose escalation of octreotide-LAR given as first-line therapy in newly diagnosed patients with acromegaly are lacking.
Read the detailed description
This is an analytical, interventional, 24-month, open, prospective study to investigate the effect of progressive increase of octreotide-LAR doses in newly diagnosed patients with acromegaly. Primary outcome measures were GH and IGF-I control and tumor shrinkage; secondary outcome measure was glucose tolerance.
At diagnosis and every six months, 24-48 hours before changes in treatment doses was applied, were measured:
- Serum IGF-I levels twice in a single sample at the time 0 of the GH profile; GH levels calculated as the mean value of 3-6 samples drawn every 30 min; the average value was considered for the statistical analysis;
- Tumor volume on MRI studies performed on clinical 1T and 1.5T scanners, using T1 weighted gradient recalled-echo in the sagittal and coronal planes, as already reported (15,21,22). The acquisitions were repeated before and after the administration of 0.1 mmoles of gadolinium chelate (diethylene-triamine pentacetate). In all patients MRI was performed at diagnosis and after 6, 12, and 24 months of treatment. The maximal sagittal, axial and coronal diameters were measured, then tumor volume was calculated by the De Chiro and Nelson formula [(volume= sagittal*coronal*axial diameters)*π/6]. According with previous studies (13,21) on post-treatment MRI, tumor shrinkage was assessed as percent decrease of tumor volume compared with baseline.
- Glucose tolerance by assaying glucose and insulin levels at fasting. Only at diagnosis glucose and insulin were also measured every 30 minutes for 2 hours after the oral administration of 75 g of glucose diluted in 250 ml of saline solution. In four patients the glucose load was not performed because of overt diabetes (fasting glucose was above 7 mmol/L at two consecutive measurements) (25). Diabetes mellitus was diagnosed in another eight patients when 2 hours after the oGTT glucose was >11 mmol/L (25). Impaired glucose tolerance (IGT) when glucose level was between >7.8 mmol/L and <11 mmol/L 2 hours after the oGTT and/or impaired fasting glucose (IFG) when glucose level was between 5.6 and 6.9 mmol/L at fasting were diagnosed in 20 patients (25). Glucose tolerance was normal (below 5.6 mmol/L at fasting) in 24 patients. To predict insulin resistance [HOMA-R (%)] and ß-cell function [HOMA-β (%)] was used the HOMA (homeostatic model assessment) according with Matthews et al. (24). By assuming that normal-weight healthy subjects aged <35 years have a HOMA-β of 100% and a HOMA-R of 1, the values for individual patients can be assessed from the insulin and glucose concentrations by the formulae: HOMA-R = [insulin (mU/L)*fasting glucose (mmol/L)] / 22.5; HOMA-β (%) = [20*insulin (mU/L)] / [glucose (mmol/L)-3.5].
Treatment protocol Before starting therapy, all patients received an acute test with s.c. octreotide at a dose of 0.1 mg in the morning after an overnight fast and at least 2 hrs of bedrest, to investigate each patient's tolerability to somatostatin analogues (25). Then, all patients were treated with octreotide-LAR i.m. at an initial dose of 20 mg every 28 days for three months. Subsequently, LAR treatment was maintained at the same dose in patients achieving GH levels ≤2.5 μg/liter and IGF-I levels in the normal range (Group A), or increased up to 30 mg every 28 days in patients with GH levels >2.5 μg/liter and/or IGF-I levels above the normal range. After another 9 months of treatment with 30 mg/q28d, the dose was maintained in 15 patients achieving GH levels ≤2.5 μg/liter and IGF-I levels in the normal range (Group B) while it was further increased to 40 mg/q28 days if fasting GH levels were still >2.5 μg/liter and/or IGF-I levels were above the normal range (Group C).
- Conditions
- Acromegaly
- Being tested
- Octreotide-LAR
- Keywords
- Acromegaly, GH, IGF-I, Pituitary tumors, Octreotide
- Medical subject headings
- Acromegaly, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide-LARDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
GH and IGF-I control
tumor shrinkage
Secondary outcomes (1)
Glucose tolerance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startJan 1995
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Investigators
- Annamaria AL Colao, Prof., Principal investigator, University Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461149
- Sponsor's protocol ID
- NeuroendoUnit-1
- Acronym
- HDacro
- Status last verified
- Apr 2007
- First submitted
- 13 Apr 2007
- Last updated
- 17 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright AD, Hill DM, Lowy C, Fraser TR. Mortality in acromegaly. Q J Med. 1970 Jan;39(153):1-16. No abstract available.
PubMed 5427331Bates AS, Van't Hoff W, Jones JM, Clayton RN. An audit of outcome of treatment in acromegaly. Q J Med. 1993 May;86(5):293-9.
PubMed 8327647Etxabe J, Gaztambide S, Latorre P, Vazquez JA. Acromegaly: an epidemiological study. J Endocrinol Invest. 1993 Mar;16(3):181-7. doi: 10.1007/BF03344942.
PubMed 8514973Rajasoorya C, Holdaway IM, Wrightson P, Scott DJ, Ibbertson HK. Determinants of clinical outcome and survival in acromegaly. Clin Endocrinol (Oxf). 1994 Jul;41(1):95-102. doi: 10.1111/j.1365-2265.1994.tb03789.x.
PubMed 8050136Abosch A, Tyrrell JB, Lamborn KR, Hannegan LT, Applebury CB, Wilson CB. Transsphenoidal microsurgery for growth hormone-secreting pituitary adenomas: initial outcome and long-term results. J Clin Endocrinol Metab. 1998 Oct;83(10):3411-8. doi: 10.1210/jcem.83.10.5111.
PubMed 9768640Swearingen B, Barker FG 2nd, Katznelson L, Biller BM, Grinspoon S, Klibanski A, Moayeri N, Black PM, Zervas NT. Long-term mortality after transsphenoidal surgery and adjunctive therapy for acromegaly. J Clin Endocrinol Metab. 1998 Oct;83(10):3419-26. doi: 10.1210/jcem.83.10.5222.
PubMed 9768641Orme SM, McNally RJ, Cartwright RA, Belchetz PE. Mortality and cancer incidence in acromegaly: a retrospective cohort study. United Kingdom Acromegaly Study Group. J Clin Endocrinol Metab. 1998 Aug;83(8):2730-4. doi: 10.1210/jcem.83.8.5007.
PubMed 9709939Ayuk J, Clayton RN, Holder G, Sheppard MC, Stewart PM, Bates AS. Growth hormone and pituitary radiotherapy, but not serum insulin-like growth factor-I concentrations, predict excess mortality in patients with acromegaly. J Clin Endocrinol Metab. 2004 Apr;89(4):1613-7. doi: 10.1210/jc.2003-031584.
PubMed 15070920Holdaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004 Feb;89(2):667-74. doi: 10.1210/jc.2003-031199.
PubMed 14764779Kauppinen-Makelin R, Sane T, Reunanen A, Valimaki MJ, Niskanen L, Markkanen H, Loyttyniemi E, Ebeling T, Jaatinen P, Laine H, Nuutila P, Salmela P, Salmi J, Stenman UH, Viikari J, Voutilainen E. A nationwide survey of mortality in acromegaly. J Clin Endocrinol Metab. 2005 Jul;90(7):4081-6. doi: 10.1210/jc.2004-1381. Epub 2005 May 10.
PubMed 15886256Freda PU, Katznelson L, van der Lely AJ, Reyes CM, Zhao S, Rabinowitz D. Long-acting somatostatin analog therapy of acromegaly: a meta-analysis. J Clin Endocrinol Metab. 2005 Aug;90(8):4465-73. doi: 10.1210/jc.2005-0260. Epub 2005 May 10.
PubMed 15886238Cozzi R, Montini M, Attanasio R, Albizzi M, Lasio G, Lodrini S, Doneda P, Cortesi L, Pagani G. Primary treatment of acromegaly with octreotide LAR: a long-term (up to nine years) prospective study of its efficacy in the control of disease activity and tumor shrinkage. J Clin Endocrinol Metab. 2006 Apr;91(4):1397-403. doi: 10.1210/jc.2005-2347. Epub 2006 Jan 31.
PubMed 16449332Bevan 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, Pivonello R, Auriemma RS, Briganti F, Galdiero M, Tortora F, Caranci F, Cirillo S, Lombardi G. Predictors of tumor shrinkage after primary therapy with somatostatin analogs in acromegaly: a prospective study in 99 patients. J Clin Endocrinol Metab. 2006 Jun;91(6):2112-8. doi: 10.1210/jc.2005-2110. Epub 2006 Mar 14.
PubMed 16537687
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effect of Dose Escalation of Octreotide-LAR as First-Line Therapy in Patients With Resistant Acromegaly
- ClinicalTrials.gov ID
- NCT00461149
- Acronym / sponsor ID
- HDacro / NeuroendoUnit-1
- Conditions
- Acromegaly
- Keywords
- Acromegaly, GH, IGF-I, Pituitary tumors, Octreotide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 1995
- Study completion
- Dec 2006 (actual)
- First posted
- 17 Apr 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.
Epidemiological data indicate that patients with active acromegaly have reduced life expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A post-treatment GH value <5 mU/liter (equal to <2.5 μg/liter) and IGF-I in the normal range for age are recognized as the most predictive survival indices.
Since their introduction into clinical use approximately two decades ago, somatostatin analogs have been considered a cornerstone of medical therapy for acromegaly. After 12 months of treatment with octreotide-LAR, control of GH and IGF-I excess, is achieved in 54% and 63% of unselected patients (11). The proportion of subjects achieving IGF-I normalization increases significantly with time (12). Significant tumor shrinkage has also been reported in a number of studies (13,14): an average 50% tumor decrease is achieved when the drug is used exclusively, or before surgery or radiotherapy (14). In 99 unselected newly diagnosed patients after 12 months of treatment with somatostatin analogues we reported control of GH levels in 57.6% and IGF-I levels in 45.5% and a greater than 50% tumor shrinkage in 44.4% (15).
The dose of LAR in different studies ranged from 10-40 mg every 28 days (q28d): high doses are generally administered in patients who do not control GH and IGF-I excess with lower doses. As reported in the meta-analysis (11) the rate of IGF-I normalization tended to be lower as octreotide-LAR dose was raised: 90% in patients treated with 10 mg, 61% with 20 mg and 53% with 30 mg. However, some further benefit by increasing the dose of octreotide-LAR was reported in some studies (16-18).
Data on dose escalation of octreotide-LAR given as first-line therapy in newly diagnosed patients with acromegaly are lacking.
Detailed description
This is an analytical, interventional, 24-month, open, prospective study to investigate the effect of progressive increase of octreotide-LAR doses in newly diagnosed patients with acromegaly. Primary outcome measures were GH and IGF-I control and tumor shrinkage; secondary outcome measure was glucose tolerance.
At diagnosis and every six months, 24-48 hours before changes in treatment doses was applied, were measured:
- Serum IGF-I levels twice in a single sample at the time 0 of the GH profile; GH levels calculated as the mean value of 3-6 samples drawn every 30 min; the average value was considered for the statistical analysis;
- Tumor volume on MRI studies performed on clinical 1T and 1.5T scanners, using T1 weighted gradient recalled-echo in the sagittal and coronal planes, as already reported (15,21,22). The acquisitions were repeated before and after the administration of 0.1 mmoles of gadolinium chelate (diethylene-triamine pentacetate). In all patients MRI was performed at diagnosis and after 6, 12, and 24 months of treatment. The maximal sagittal, axial and coronal diameters were measured, then tumor volume was calculated by the De Chiro and Nelson formula [(volume= sagittal*coronal*axial diameters)*π/6]. According with previous studies (13,21) on post-treatment MRI, tumor shrinkage was assessed as percent decrease of tumor volume compared with baseline.
- Glucose tolerance by assaying glucose and insulin levels at fasting. Only at diagnosis glucose and insulin were also measured every 30 minutes for 2 hours after the oral administration of 75 g of glucose diluted in 250 ml of saline solution. In four patients the glucose load was not performed because of overt diabetes (fasting glucose was above 7 mmol/L at two consecutive measurements) (25). Diabetes mellitus was diagnosed in another eight patients when 2 hours after the oGTT glucose was >11 mmol/L (25). Impaired glucose tolerance (IGT) when glucose level was between >7.8 mmol/L and <11 mmol/L 2 hours after the oGTT and/or impaired fasting glucose (IFG) when glucose level was between 5.6 and 6.9 mmol/L at fasting were diagnosed in 20 patients (25). Glucose tolerance was normal (below 5.6 mmol/L at fasting) in 24 patients. To predict insulin resistance [HOMA-R (%)] and ß-cell function [HOMA-β (%)] was used the HOMA (homeostatic model assessment) according with Matthews et al. (24). By assuming that normal-weight healthy subjects aged <35 years have a HOMA-β of 100% and a HOMA-R of 1, the values for individual patients can be assessed from the insulin and glucose concentrations by the formulae: HOMA-R = [insulin (mU/L)*fasting glucose (mmol/L)] / 22.5; HOMA-β (%) = [20*insulin (mU/L)] / [glucose (mmol/L)-3.5].
Treatment protocol Before starting therapy, all patients received an acute test with s.c. octreotide at a dose of 0.1 mg in the morning after an overnight fast and at least 2 hrs of bedrest, to investigate each patient's tolerability to somatostatin analogues (25). Then, all patients were treated with octreotide-LAR i.m. at an initial dose of 20 mg every 28 days for three months. Subsequently, LAR treatment was maintained at the same dose in patients achieving GH levels ≤2.5 μg/liter and IGF-I levels in the normal range (Group A), or increased up to 30 mg every 28 days in patients with GH levels >2.5 μg/liter and/or IGF-I levels above the normal range. After another 9 months of treatment with 30 mg/q28d, the dose was maintained in 15 patients achieving GH levels ≤2.5 μg/liter and IGF-I levels in the normal range (Group B) while it was further increased to 40 mg/q28 days if fasting GH levels were still >2.5 μg/liter and/or IGF-I levels were above the normal range (Group C).
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)
- patients with newly diagnosed acromegaly
- age above 18 years
- no previous treatments for acromegaly
Key exclusion criteria (4 listed)
- primary surgery
- concomitant hyperprolactinemia if requiring combined treatment with dopamine-agonist
- primary treatment with lanreotide
- treatment duration less than 24 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 |
|---|---|---|
| Octreotide-LAR | Drug | – |
Primary outcome
GH and IGF-I control
tumor shrinkage
1 secondary outcome
Glucose tolerance.
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 17 Apr 2007.
- Results publication: PubMed 5427331Wright AD, Hill DM, Lowy C, Fraser TR. Mortality in acromegaly. Q J Med. 1970 Jan;39(153):1-16. No abstract available.
- Results publication: PubMed 8327647Bates AS, Van't Hoff W, Jones JM, Clayton RN. An audit of outcome of treatment in acromegaly. Q J Med. 1993 May;86(5):293-9.
- Results publication: PubMed 8514973Etxabe J, Gaztambide S, Latorre P, Vazquez JA. Acromegaly: an epidemiological study. J Endocrinol Invest. 1993 Mar;16(3):181-7. doi: 10.1007/BF03344942.
- Results publication: PubMed 8050136Rajasoorya C, Holdaway IM, Wrightson P, Scott DJ, Ibbertson HK. Determinants of clinical outcome and survival in acromegaly. Clin Endocrinol (Oxf). 1994 Jul;41(1):95-102. doi: 10.1111/j.1365-2265.1994.tb03789.x.
- Results publication: PubMed 9768640Abosch A, Tyrrell JB, Lamborn KR, Hannegan LT, Applebury CB, Wilson CB. Transsphenoidal microsurgery for growth hormone-secreting pituitary adenomas: initial outcome and long-term results. J Clin Endocrinol Metab. 1998 Oct;83(10):3411-8. doi: 10.1210/jcem.83.10.5111.
- Results publication: PubMed 9768641Swearingen B, Barker FG 2nd, Katznelson L, Biller BM, Grinspoon S, Klibanski A, Moayeri N, Black PM, Zervas NT. Long-term mortality after transsphenoidal surgery and adjunctive therapy for acromegaly. J Clin Endocrinol Metab. 1998 Oct;83(10):3419-26. doi: 10.1210/jcem.83.10.5222.
- Results publication: PubMed 9709939Orme SM, McNally RJ, Cartwright RA, Belchetz PE. Mortality and cancer incidence in acromegaly: a retrospective cohort study. United Kingdom Acromegaly Study Group. J Clin Endocrinol Metab. 1998 Aug;83(8):2730-4. doi: 10.1210/jcem.83.8.5007.
- Results publication: PubMed 15070920Ayuk J, Clayton RN, Holder G, Sheppard MC, Stewart PM, Bates AS. Growth hormone and pituitary radiotherapy, but not serum insulin-like growth factor-I concentrations, predict excess mortality in patients with acromegaly. J Clin Endocrinol Metab. 2004 Apr;89(4):1613-7. doi: 10.1210/jc.2003-031584.
- Results publication: PubMed 14764779Holdaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004 Feb;89(2):667-74. doi: 10.1210/jc.2003-031199.
- Results publication: PubMed 15886256Kauppinen-Makelin R, Sane T, Reunanen A, Valimaki MJ, Niskanen L, Markkanen H, Loyttyniemi E, Ebeling T, Jaatinen P, Laine H, Nuutila P, Salmela P, Salmi J, Stenman UH, Viikari J, Voutilainen E. A nationwide survey of mortality in acromegaly. J Clin Endocrinol Metab. 2005 Jul;90(7):4081-6. doi: 10.1210/jc.2004-1381. Epub 2005 May 10.
- Results publication: PubMed 15886238Freda PU, Katznelson L, van der Lely AJ, Reyes CM, Zhao S, Rabinowitz D. Long-acting somatostatin analog therapy of acromegaly: a meta-analysis. J Clin Endocrinol Metab. 2005 Aug;90(8):4465-73. doi: 10.1210/jc.2005-0260. Epub 2005 May 10.
- Results publication: PubMed 16449332Cozzi R, Montini M, Attanasio R, Albizzi M, Lasio G, Lodrini S, Doneda P, Cortesi L, Pagani G. Primary treatment of acromegaly with octreotide LAR: a long-term (up to nine years) prospective study of its efficacy in the control of disease activity and tumor shrinkage. J Clin Endocrinol Metab. 2006 Apr;91(4):1397-403. doi: 10.1210/jc.2005-2347. Epub 2006 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.
Annamaria AL Colao, Prof. principal investigator
University Federico II
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 Octreotide-LAR 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 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 17 Apr 2007. 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?
GH and IGF-I control. The study lists 2 primary outcomes in all. 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 NCT00461149, which also lists 25 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 17 Apr 2007.