AcromegalyNCT01014793
Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients
An observational study of Acromegaly, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acromegaly
- What is being tested?
- cabergoline
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- May 2005to Dec 2008
- Phase
- Observational
- 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
Study population: Nineteen acromegalic patients (Neuroendocrine Unit-UNIFESP)with active disease, resistant to octreotide were enrolled
Who may be able to join
- Active disease, under octreotide treatment at least 9 months
Who cannot join
- Cabergoline allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly
In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.
- Conditions
- Acromegaly
- Being tested
- cabergoline
- Keywords
- Acromegaly resistant, combined-treatment, dopamine agonist
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabergolineDrug
Also called cabergoline-Dostinex
cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Responders to cabergoline | patients with active disease under octreotide treatment received addition of increasing doses of cabergoline (1.0, 2.0 and 3.5mg/week) Receives: Drug: cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of IGF-I levels
Measured: six months
Secondary outcomes (1)
control IGI-I levels
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startMay 2005
- Primary completionMay 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Julio Abucham, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014793
- Sponsor's protocol ID
- Mattapr1
- Status last verified
- Nov 2009
- First submitted
- 16 Nov 2009
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rocheville M, Lange DC, Kumar U, Sasi R, Patel RC, Patel YC. Subtypes of the somatostatin receptor assemble as functional homo- and heterodimers. J Biol Chem. 2000 Mar 17;275(11):7862-9. doi: 10.1074/jbc.275.11.7862.
PubMed 10713101Holdaway 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 14764779Melmed S, Colao A, Barkan A, Molitch M, Grossman AB, Kleinberg D, Clemmons D, Chanson P, Laws E, Schlechte J, Vance ML, Ho K, Giustina A; Acromegaly Consensus Group. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009 May;94(5):1509-17. doi: 10.1210/jc.2008-2421. Epub 2009 Feb 10.
PubMed 19208732Cozzi R, Attanasio R, Lodrini S, Lasio G. Cabergoline addition to depot somatostatin analogues in resistant acromegalic patients: efficacy and lack of predictive value of prolactin status. Clin Endocrinol (Oxf). 2004 Aug;61(2):209-15. doi: 10.1111/j.1365-2265.2004.02082.x.
PubMed 15272916Selvarajah D, Webster J, Ross R, Newell-Price J. Effectiveness of adding dopamine agonist therapy to long-acting somatostatin analogues in the management of acromegaly. Eur J Endocrinol. 2005 Apr;152(4):569-74. doi: 10.1530/eje.1.01888.
PubMed 15817912Abs R, Verhelst J, Maiter D, Van Acker K, Nobels F, Coolens JL, Mahler C, Beckers A. Cabergoline in the treatment of acromegaly: a study in 64 patients. J Clin Endocrinol Metab. 1998 Feb;83(2):374-8. doi: 10.1210/jcem.83.2.4556.
PubMed 9467544Rocheville M, Lange DC, Kumar U, Patel SC, Patel RC, Patel YC. Receptors for dopamine and somatostatin: formation of hetero-oligomers with enhanced functional activity. Science. 2000 Apr 7;288(5463):154-7. doi: 10.1126/science.288.5463.154.
PubMed 10753124Jallad RS, Bronstein MD. Optimizing medical therapy of acromegaly: beneficial effects of cabergoline in patients uncontrolled with long-acting release octreotide. Neuroendocrinology. 2009;90(1):82-92. doi: 10.1159/000218323. Epub 2009 May 8.
PubMed 19439914Gatta B, Hau DH, Catargi B, Roger P, Tabarin A. Re-evaluation of the efficacy of the association of cabergoline to somatostatin analogues in acromegalic patients. Clin Endocrinol (Oxf). 2005 Oct;63(4):477-8. doi: 10.1111/j.1365-2265.2005.02329.x. No abstract available.
PubMed 16181243
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly
- ClinicalTrials.gov ID
- NCT01014793
- Acronym / sponsor ID
- Mattapr1
- Conditions
- Acromegaly
- Keywords
- Acromegaly resistant, combined-treatment, dopamine agonist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Nov 2009 (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.
In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Responders to cabergoline | – | Drug: cabergolinepatients with active disease under octreotide treatment received addition of increasing doses of cabergoline (1.0, 2.0 and 3.5mg/week) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nineteen acromegalic patients (Neuroendocrine Unit-UNIFESP)with active disease, resistant to octreotide were enrolled
Key inclusion criteria (1 listed)
- Active disease, under octreotide treatment at least 9 months
Key exclusion criteria (1 listed)
- Cabergoline allergy
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 |
|---|---|---|
| cabergolineAlso: cabergoline-Dostinexcabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal | Drug | Responders to cabergoline |
Primary outcome
Control of IGF-I levels
Time frame: six months
1 secondary outcome
control IGI-I levels
Time frame: six 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 17 Nov 2009.
- Background: PubMed 10713101Rocheville M, Lange DC, Kumar U, Sasi R, Patel RC, Patel YC. Subtypes of the somatostatin receptor assemble as functional homo- and heterodimers. J Biol Chem. 2000 Mar 17;275(11):7862-9. doi: 10.1074/jbc.275.11.7862.
- Background: 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.
- Background: PubMed 19208732Melmed S, Colao A, Barkan A, Molitch M, Grossman AB, Kleinberg D, Clemmons D, Chanson P, Laws E, Schlechte J, Vance ML, Ho K, Giustina A; Acromegaly Consensus Group. Guidelines for acromegaly management: an update. J Clin Endocrinol Metab. 2009 May;94(5):1509-17. doi: 10.1210/jc.2008-2421. Epub 2009 Feb 10.
- Results publication: PubMed 15272916Cozzi R, Attanasio R, Lodrini S, Lasio G. Cabergoline addition to depot somatostatin analogues in resistant acromegalic patients: efficacy and lack of predictive value of prolactin status. Clin Endocrinol (Oxf). 2004 Aug;61(2):209-15. doi: 10.1111/j.1365-2265.2004.02082.x.
- Results publication: PubMed 15817912Selvarajah D, Webster J, Ross R, Newell-Price J. Effectiveness of adding dopamine agonist therapy to long-acting somatostatin analogues in the management of acromegaly. Eur J Endocrinol. 2005 Apr;152(4):569-74. doi: 10.1530/eje.1.01888.
- Results publication: PubMed 9467544Abs R, Verhelst J, Maiter D, Van Acker K, Nobels F, Coolens JL, Mahler C, Beckers A. Cabergoline in the treatment of acromegaly: a study in 64 patients. J Clin Endocrinol Metab. 1998 Feb;83(2):374-8. doi: 10.1210/jcem.83.2.4556.
- Results publication: PubMed 10753124Rocheville M, Lange DC, Kumar U, Patel SC, Patel RC, Patel YC. Receptors for dopamine and somatostatin: formation of hetero-oligomers with enhanced functional activity. Science. 2000 Apr 7;288(5463):154-7. doi: 10.1126/science.288.5463.154.
- Results publication: PubMed 19439914Jallad RS, Bronstein MD. Optimizing medical therapy of acromegaly: beneficial effects of cabergoline in patients uncontrolled with long-acting release octreotide. Neuroendocrinology. 2009;90(1):82-92. doi: 10.1159/000218323. Epub 2009 May 8.
- Results publication: PubMed 16181243Gatta B, Hau DH, Catargi B, Roger P, Tabarin A. Re-evaluation of the efficacy of the association of cabergoline to somatostatin analogues in acromegalic patients. Clin Endocrinol (Oxf). 2005 Oct;63(4):477-8. doi: 10.1111/j.1365-2265.2005.02329.x. No abstract available.
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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.
Julio Abucham, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Federal University of São Paulo at 1 site in Brazil.
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 1 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 Nov 2009. 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 Brazil. 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.
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 IGF-I levels (time frame: six 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 NCT01014793, which also lists 9 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 Nov 2009.