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

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acromegaly

Intervention: cabergoline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Julio Abucham, PhD, Study Director, Affiliation: Federal University of São Paulo

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. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.

Clinical Details

Official title: Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Control of IGF-I levels

Secondary outcome: control IGI-I levels

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Active disease, under octreotide treatment at least 9 months

Exclusion Criteria:

- Cabergoline allergy

Locations and Contacts

Federal University of Sao Paulo, Sao Paulo, SP 04039030, Brazil
Additional Information

Related 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.

Holdaway IM, Rajasoorya RC, Gamble GD. Factors influencing mortality in acromegaly. J Clin Endocrinol Metab. 2004 Feb;89(2):667-74.

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. Review.

Starting date: May 2005
Last updated: November 16, 2009

Page last updated: August 23, 2015

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