Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients

NCT ID: NCT01014793

Last Updated: 2009-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acromegaly

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

cabergoline

Intervention Type DRUG

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

Interventions

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cabergoline

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

Intervention Type DRUG

Other Intervention Names

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cabergoline-Dostinex

Eligibility Criteria

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Inclusion Criteria

* Active disease, under octreotide treatment at least 9 months

Exclusion Criteria

* Cabergoline allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Sao Paulo

Principal Investigators

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Julio Abucham, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Locations

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Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 10713101 (View on PubMed)

Holdaway 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.

Reference Type BACKGROUND
PMID: 14764779 (View on PubMed)

Melmed 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.

Reference Type BACKGROUND
PMID: 19208732 (View on PubMed)

Cozzi 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.

Reference Type RESULT
PMID: 15272916 (View on PubMed)

Selvarajah 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.

Reference Type RESULT
PMID: 15817912 (View on PubMed)

Abs 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.

Reference Type RESULT
PMID: 9467544 (View on PubMed)

Rocheville 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.

Reference Type RESULT
PMID: 10753124 (View on PubMed)

Jallad 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.

Reference Type RESULT
PMID: 19439914 (View on PubMed)

Gatta 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.

Reference Type RESULT
PMID: 16181243 (View on PubMed)

Other Identifiers

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Mattapr1

Identifier Type: -

Identifier Source: org_study_id

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